04T13 - Uric Acid2 - Stability - IRIS V1

Uric Acid2
Stability
Uric Acid2 Stability

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September 2020 CONFIDENTIAL Page 1 of 106
Table of Contents
Page
I. Introduction.................................................................................................................3
II. Stability Dating and Kit Components.........................................................................3
Uric Acid2 Reagent Kit (List No. 04T1320 / 04T1330)............................................3
III. Reagent Developmental Stability Studies..................................................................3
A. Uric Acid2 Reagent Developmental Stability......................................................3
1. Purpose...........................................................................................................3
2. Procedure........................................................................................................4
3. Evaluation/Results........................................................................................12
a. Stability Action Limit Evaluation/Results..............................................12
b. Regression Analysis Evaluation/Results................................................14
c. Shift Analysis Evaluation/Results..........................................................15
d. Dating Assignment.................................................................................15
4. Conclusion....................................................................................................16

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I. Introduction
The stability study presented in this chapter applies to the Uric Acid2 (List No. 04T13)
assay for use on the ARCHITECT c System.
The study was conducted between August 31, 2017 and January 23, 2020 internally at
Abbott Ireland Diagnostics Division, Longford, Ireland. The individual responsible for
the studies was James McRedmond. Individuals that performed the testing were trained
on the respective protocols.
II. Stability Dating and Kit Components
The dating of the Uric Acid2 Reagent master lot is provided below.
Uric Acid2 Reagent Kit (List No. 04T1320 / 04T1330)
Component List No. Expiration Dating

Reagent 1 (R1) 04T13R 15 Months
Reagent 2 (R2) 04T13T 15 Months
III. Reagent Developmental Stability Studies
A. Uric Acid2 Reagent Developmental Stability
1. Purpose
The purpose of this study was to demonstrate the stability of the Uric Acid2
Reagent Kit (List No. 04T13) when subjected to the following conditions:
Stability Conditions Number of Lots

Intended Storage (IS) 6^
In-Use (IU) 1
Inverted Storage (INV) 1
On-Board Storage (OBS) 6^
Packaging, Operations, Exposure Limits (POEL) 1
Transport Temperature Simulation (Transport) 1
^ Two additional lots for Intended Storage and On-Board Storage were tested to ensure a
minimum of 3 biochemically active lots were used to establish dating.
The IS condition was performed to establish the expiration dating of the Uric
Acid2 Reagent Kit when stored at the recommended storage temperature
(2 to 8°C).
The IU condition was performed to demonstrate the stability of the

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Uric Acid2 Reagent Kit while simulating customer use over time
The INV condition was performed to demonstrate stability of the

Uric Acid2 Reagent Kit when the reagent kit is stored in an inverted position.
The POEL condition was performed to demonstrate stability of the

Uric Acid2 Reagent Kit while simulating packaging and operations exposure.
The Transport condition was performed to demonstrate reagent stability while

simulating the shipping of the Uric Acid2 Reagent Kit from the manufacturing
site to customers.
The OBS condition was performed to support the storage of the Uric Acid2
Reagent Kit 4 x 160 and 4 x 500 test kit reagents on board the instrument for a
minimum of 30 days.
2. Procedure
This stability study was performed using a real-time stability study design based
on guidance from the Clinical and Laboratory Standards Institute (CLSI)
Document EP25-A.
The following stability conditions and time points were performed for the study.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
CLSI Document EP25-A. Wayne, PA: CLSI; 2009.

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Time
Points IS IU INV POEL Transport Transport + OBS OBS
Month 0 -
X § § §,X - -
(Time 0)
Month 1 X - - - - - -
Month 2 X - - - - - X
Transport Stress 1 -
Month 3 X X X - -
(stress and test)
Month 4 X - - - - - -
Month 5 X - - - - - -
Month 6 X X X - Transport Stress 1 (test) - -
Month 7 X - - - - - -
Month 8 X - - - - - X
Month 9 X X X - Transport Stress 1 (test) - -
Month 10 X - - - - - -
Month 11 X - - - - - -
Transport Stress 1 OBS
Transport Stress 1 (test)
(stress and test)
Month 12 X X X - Transport Stress 2 -
(stress and test)
(stress and test)
Month 13 X - - - - - -
Month 14 X - - - - - -
Transport Stress 1 (test)
(stress and test)
Month 15^ X X X - Transport Stress 3 X
(stress and test)
(stress and test)
Month 16 X - - - - - -
§ The IS Baseline/Month 0 result was used as the Baseline/Month 0 for the INV, IU and
POEL baseline results.
^ Crossover testing was performed at month 15 for urine to cross over from an old lot of
reference controls to a new lot of reference controls.

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Additional IS and OBS Testing
Time
Points IS OBS
Month 0 X -
Month 1 X -
Month 2 X X
Month 3 X -
Month 4 X -
Month 5 X -
Month 6 X X
Month 7 X -
Month 8 X X
Month 9# X -
Month 10 X -
Month 11 X -
Month 12 X X
Month 13* X -
Month 14 X -
Month 15 X X
Month 16 X -
# Crossover testing was performed at month 9 to cross over to a new lot of BioRad
Liquichek Urine Chemistry Controls for Uric Acid2 urine.
* Crossover testing was performed at month 13 to cross over to a new lot of BioRad
Lyphochek Unassayed Chemistry Controls for Uric Acid2 serum.
For each time point/stability condition, the reagent kits were calibrated and
then evaluated by testing the reference controls in the required number of
runs, where a run was defined as testing the following materials on 1
instrument in the minimum number of replicates shown in the table below:
Minimum
Stability Number of
Condition Testing Material Replicates
Reference Controls, Urine (Liquichek
All Conditions* 5
Unassayed Controls Level 1, 2)
Reference Controls, Serum (Lyphochek
All Conditions* 5
Unassayed Controls Level 1, 2)
Additional IS & Reference Controls, Urine (Liquichek
15
OBS Unassayed Controls Level 1, 2)
Additional IS & Reference Controls, Serum (Lyphochek
16
OBS Unassayed Controls Level 1, 2)
* Applicable to testing completed with Lot 1 through Lot 4

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On-Test Material Information
The Uric Acid2 Reagent Kits listed in the table below were the on-test
materials for this stability.
Stability Lot
List 1 2 3 4
Component Number (Mfg. Date) (Mfg. Date) (Mfg. Date) (Mfg. Date)
UACI10026 UACI10040 N/A
Uric Acid2 Reagent UACI10012
04T1330 (02-Aug- (08-Aug-
Kit (4 x 500) (31-Jul-2017)
2017) 2017)
Uric Acid2 Reagent UACI10039
04T1320 N/A N/A N/A
Kit (4 x 160) (08-Aug-2017)
Mfg. = Manufacturing
Note: Stability Lot 1, 2, 3 and 4 were used for IS and OBS conditions. Stability Lot 1 was
used for the IU condition. Stability Lot 4 was used for POEL, Transport, and INV
conditions.
Additional Stability Lots

List 5 6
Component Number (Mfg. Date) (Mfg. Date)
Uric Acid2 Reagent 93917UI00 93918UI00
04T1330
Kit (4 x 500) (08-Aug-2018) (14-Aug-2018)
Mfg. = Manufacturing
Note: Additional Stability Lot 5 and Lot 6 were used for Additional IS and OBS testing, and
both lots (93917UI00 and 93918UI00) are documented in the tables and plots.
All reagents were stored continuously at the recommended storage

temperature (2 to 8°C) prior to the initiation of the stability conditions.
Reference Materials Information
The materials listed in the table below were the reference materials used to
evaluate the on-test reagents in the study.
Storage
Component
Condition
Clinical Chemistry Calibrator Serum Level 3 2 to 8°C
Lyphochek Unassayed Chemistry Control (Human) Level 1* 2 to 8°C
Lyphochek Unassayed Chemistry Control (Human) Level 2* 2 to 8°C
Liquichek Urine Chemistry Control Level 1** 2 to 8°C
Liquichek Urine Chemistry Control Level 2** 2 to 8°C
* BioRad Lyphochek Unassayed Chemistry Control (Human) Levels 1 and 2 are abbreviated
as BioRad Controls Level 1 and 2 throughout the document
** BioRad Liquichek Urine Chemistry Control Levels 1 and 2 are abbreviated as BioRad
Urine Controls Level 1 and 2 throughout the document.

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Preparation of Materials
The Clinical Chemistry Calibrator Serum Level 3 was reconstituted by pipetting

precisely 5 mL of distilled water at 15 to 25°C into the vial. The stopper was
replaced, and the vial was left to stand for 30 minutes before use. The vial was
gently swirled several times during the reconstitution period to ensure that the
contents were completely dissolved. Prior to use, the vial was inverted to mix
the contents, taking care not to shake the vial to avoid foam formation. The
reconstituted material was stable for 8 hours at 15 to 25°C, 7 days at 2 to 8°C,
and 28 days at -20°C when frozen once.
The BioRad Lyphochek Unassayed Chemistry Control (Human) Level 1 and

Level 2 were reconstituted using a volumetric pipette by adding the volume of
distilled or deionised water indicated on the vial label. The stoppers were
replaced and the vials left to stand for a minimum of 20 minutes, swirling
occasionally. Before use, the vials were swirled several times to ensure
homogeneity. The reconstituted materials were stored at 2 to 8ºC and used
within 24 hours of opening.
The BioRad Liquichek Urine Chemistry Control Level 1 and Level 2 were
allowed to reach room temperature (18 to 25°C). Before use, the vials were
swirled several times to ensure homogeneity. After use, the stoppers were
promptly replaced on the vials, and the vials were returned to 2 to 8°C storage.
The materials were used within 24 hours of opening.
Stability Conditions
Intended Storage (IS)

The Uric Acid2 Reagent Kits designated for the IS condition were stored
at 2 to 8°C. At Time 0 (Baseline), three runs were performed with each IS
reagent lot on the ARCHITECT c8000 instrument. At each subsequent
monthly time point (Month 1 through Month 16), a minimum of 1 run was
performed with each IS reagent lot on the ARCHITECT c8000 instrument.

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In-Use (IU)
At Time 0 (Baseline), the Uric Acid2 Reagent Kits designated for the IU
condition were opened and placed on board the ARCHITECT c8000
instrument and were tested only to pipette the reagents and mimic
customer use. After the time point, the reagent kits were capped and stored
off the instrument at the recommended storage condition.
At Month 3, the Uric Acid2 Reagent Kits designated for the IU condition
were opened once again and placed on board the ARCHITECT c8000
instrument. One of the IU reagent kits was tested and evaluated against the
stability action limits. All remaining IU reagent kits were tested only to
pipette the reagents and mimic customer use. These reagent kits were then
capped and stored off the instrument at the recommended storage
condition.
At the next time point, the Uric Acid2 Reagent Kits designated for the IU
condition were once again opened and placed on board the ARCHITECT
c8000 instrument. A different IU reagent kit than the IU reagent kit
evaluated during the previous time point was tested and evaluated against
the stability action limits. All remaining IU reagent kits were tested only
to pipette the reagents and mimic customer use. These reagent kits were
then capped and stored off the instrument at the recommended storage
condition.
At each subsequent time point, the process above was repeated.
Inverted Storage (INV)

At Time 0 (Baseline), the Uric Acid2 Reagent Kits designated for the INV
condition were inverted and stored continuously at the recommended
storage temperature (2 to 8°C) in an inverted position so that the reagent
material was in contact with the container closure for the remainder of the
study.
At each subsequent time point, the INV-stressed reagent(s) were tested on

the ARCHITECT c8000 instrument.
Packaging Operations Exposure Limits (POEL)

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At Time 0 (Baseline), the Uric Acid2 Reagent Kits designated for the
POEL condition were stored at the POEL temperature (27 ± 2°C) for 121
hours.
The POEL-stressed reagent(s) were tested on the ARCHITECT c8000

instrument.
Transport Temperature Simulation (Transport)

Transport Stress 1 (Ambient Transport)
Prior to the Month 3 time point, Uric Acid2 Reagent Kits designated for the
Transport condition (Transport Stress 1) were subjected to the following
Transport Temperature Simulation cycle:
Temperature Cycle Duration

15 to 30°C 161.6 – 174.0 hours (6.8 – 7.25 days)
25°C ± 2°C 71.7 – 78.0 hours (3 – 3.25 days)
30°C ± 2°C 6.1 – 6.5 hours
35°C ± 2°C 1.0 – 1.25 hours
40°C ± 2°C 1.0 – 1.25 hours
After the Transport stress was completed, the Transport-stressed reagent(s) from
Transport Stress 1 (stressed prior to Month 3) were stored at the recommended
storage condition until tested, where the Transport-stressed reagent(s) were
required to be tested within 14 days of the completed Transport Temperature
Simulation cycle.
At Month 3 and at each subsequent time point (Months 6, 9, 12, and 15), the
Transport-stressed reagent(s) from Transport Stress 1 (stressed prior to Month 3)
were tested on the ARCHITECT c8000 instrument. In addition, an unstressed
reagent kit was tested during the same test points as the Transport-stressed
reagent kits.
Transport Stress 2 and 3 (Ambient Transport)

Prior to the Month 12 and 15 time point(s), the Transport Temperature
Simulation cycle above was repeated with Uric Acid2 Reagent Kits designated

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for the Transport condition (Transport Stress 2, 3) and the Transport-stressed
reagent(s) were stored at the recommended storage condition until tested.
After the Transport stress was completed, the Transport-stressed reagent(s) from
Transport Stress 2 (stressed prior to Month 12) and Transport Stress 3 (stressed
prior to Month 15) were removed from recommended storage condition and
tested on the ARCHITECT c8000 instrument. In addition, an unstressed reagent
kit was tested during the same test points as the Transport-stressed reagent kits.
Transport Temperature Simulation (Transport) + On Board Storage (OBS)

At Month 12, the Transport-stressed reagent(s) from Transport Stress 1
and 2 were removed from the recommended storage condition and placed
on the ARCHITECT c16000 instrument within 14 days of the completed
Transport Temperature Simulation cycle for Transport Stress 2.
At Month 15, the Transport-stressed reagent(s) from Transport Stress 1

and 3 were removed from the recommended storage condition and placed
on the ARCHITECT c16000 instrument within 14 days of the completed
Transport Temperature Simulation cycle for Transport Stress 3.
The Transport-stressed reagent(s) were to be stored on board for a

minimum of 30 days, with testing performed on Day 0 and minimally, on
Day 31. While the OBS reagent kits were stored on the instrument, the
refrigeration mode was kept on. The calibration curve generated at Day 0
for each OBS time point (Month 12 and Month 15) was used for the
duration of that time point. In addition, an unstressed reagent kit was
tested during the same Day 0 test point as the Transport+OBS reagent kits.
On Board Storage (OBS)

At the Month 2 time point, Uric Acid2 Reagent Kits from each reagent lot
designated for the OBS condition were placed on the ARCHITECT
c16000 instrument, to be stored on board for a minimum of 30 days, with
testing performed on Day 0 and minimally, on Day 31. While the OBS
reagent kit was stored on the instrument, the refrigeration mode was kept

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on. The calibration curve generated at Day 0 for each OBS time point was
used for the duration of that time point. At each subsequent time point, the
process above was repeated.
3. Evaluation/Results
The acceptability of the Uric Acid2 reagent stability was determined by

performing
 a stability action limit evaluation for all stability conditions with the
exception of the additional IS and OBS conditions
 a regression analysis for all IS, IU, and INV conditions
 a stability shift analysis for all OBS, POEL, Transport, and Transport +
OBS conditions
a. Stability Action Limit Evaluation/Results
The acceptability of the Uric Acid2 reagent stability was determined using
the stability action limits presented in the table below. BioRad Urine Control
Levels 1 and 2 (Lots 66791 and 66792) were used from Baseline/Month 0 to
Month 15, when crossover testing was performed. The new BioRad Urine
Control Levels 1 and 2 (Lots 66801 and 66802) was used for testing at Month
15 until completion of the study.
Stability
Stability Stability Action Limits
Condition(s) Sample Indicator (mg/dL)
Control Level 1, Lot 15671 Individual replicate values 4.3 to 5.4
Control Level 2, Lot 15672 Individual replicate values 9.0 to 11.6
Urine Control Level 1, Lot 66791 Individual replicate values 3.3 to 17.2
All Conditions
The descriptive statistics for each reagent stability condition are presented in
Figure III.A.1 to Figure III.A.14.
For presentation of the data, given that the limits of all the Urine controls
shared a difference of 13.9 mg/dL, the stability action limits were combined
in the figures by taking the maximum value of the lower specification limits

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and the minimum value for the upper specification limits. The combined
limits are as follows:
Combined Stability Action Limit

Sample (mg/dL)
Urine Control Level 1 3.3 to 16.6
Urine Control Level 2 14.0 to 23.5
The stability action limits were met for all conditions and time points
evaluated.
The descriptive statistics for each reagent stability condition are presented in
Table III.A.1 through Table III.A.18.
For Additional IS and Additional OBS conditions, the stability action limits
were not assessed. The additional lots were assessed using a regression
analysis and a stability shift analysis (see section b and c).
Crossover evaluations are conducted when reference material substitutions

occur. The differences between the control concentrations are compared, and
adjustments are made to the control concentrations after material substitution
for the purposes of the regression analysis. The reason to make these
adjustments is to ensure that the change in reference material does not cause
an impact to the stability analysis in terms of degradation over time.
Therefore, the unadjusted values are assessed against the stability action
limits, but the adjusted values after crossover are analyzed in the regression
analysis.1
BioRad Urine Control Levels 1 and 2 (Lots 68501 and 68502) were used
from Baseline/Month 0 to Month 09, when crossover testing was performed
in the Additional IS condition. The new BioRad Urine Control Levels 1 and 2
(Lots 68531 and 68532) was used for testing at Month 09 until completion of
the study for Additional IS and Additional OBS conditions. BioRad Serum
Control Levels 1 and 2 (Lots 15681 and 15682) were used from
Baseline/Month 0 to Month 13, when crossover testing was performed in the
1
For IS, crossover adjustment was applied automatically by the software system used to perform the data analysis. For
IU and INV, crossover adjustment was applied manually offline and adjusted values are presented in the tables.

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Additional IS condition. The new BioRad Urine Control Levels 1 and 2 (Lots
15691 and 15692) was used for testing at Month 13 until completion of the
study for Additional IS and Additional OBS conditions.
b. Regression Analysis Evaluation/Results
Using the slope and Standard Error (SE) from the regression analysis, the
shift and % shift and SE of the shift and % shift from Time 0 (Baseline) were
calculated at 16 months for IS and at 15 months for IU and INV, and the
results were evaluated against the maximum allowable stability shift
allowances for each condition as shown in the table below.
Stability Condition(s) Stability

Indicator Specification Limits
IS, IU, INV Percent Shift/Shift by slope
±6% or ±0.29 mg/dL,
(Serum) from condition baseline
whichever is greater
IS, IU, INV Percent Shift/Shift by slope
±10% or ±3.1 mg/dL,
(Urine) from condition baseline
whichever is greater
The regression specification limits were met for each sample/reagent

lots/time point combination. The shift and % shift values are presented in

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c. Shift Analysis Evaluation/Results
The shift and % shift were calculated for each test sample/reagent lot/test
point combination and the results were evaluated against the stability shift
allowances for each condition as shown in the table below.
Stability
Stability Condition(s) Indicator Specification Limits
OBS (Serum) Percent Shift / Shift from
OBS Day 0 for each sample
mean
Transport (Serum) Percent Shift from non-
stressed kits for each sample ±6% or ±0.29 mg/dL,
mean whichever is greater
Transport + OBS
(Serum) Percent Shift from non-
stressed OBS Day 0 for each
sample mean
OBS (Urine) Percent Shift / Shift from

OBS Day 0 for each sample
mean
Transport (Urine)
Percent Shift from non-
stressed kits for each sample ±10% or ±3.1 mg/dL,
mean whichever is greater
Transport + OBS (Urine)

Percent Shift from non-
stressed kits for each sample
mean
The shift specification limits were met for each test sample/reagent lot/time
point or test point combination. The shift and % shift values are presented in
d. Dating Assignment
The dating for the Uric Acid2 Reagent Kit was assigned as up to 15 months
based on the 16 months of stability data points obtained in this study, the
acceptable regression analysis at 16 months for the IS condition, and the
acceptable shift analysis for the OBS condition at Month 15, Day 31.

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4. Conclusion
The data from the IS condition support expiration dating of up to 15 months for
the reagent(s) at the recommended storage condition (2 to 8°C).
The data from the IU condition demonstrated reagent stability during simulated
customer use over time.
The data from the INV condition demonstrated reagent stability when the
reagent(s) were stored in an inverted position.
The data from the POEL condition demonstrated reagent stability during
packaging and operations exposure for 121 hours.
The data from the Transport condition demonstrated reagent stability following
transport at ambient shipping conditions.
The data from the OBS condition support the storage of the reagent(s) on board
the instrument for up to 30 days.

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Table III.A.1
Uric Acid2 Reagent Developmental Stability
On-Test Material: Reagent Lot 1 (4 x 500 Tests)
Condition: Intended Storage (IS)
Serum Samples
Sample: Lyphochek Unassayed CC Level 1 Sample: Lyphochek Unassayed CC Level 2

Adj. Adj.
Test Test
Test Test
Test Mean Test Test Test Mean Test Test
Test Point Mean Test Point Mean
N (mg/dL SD %CV N (mg/dL SD %CV
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 4.8 0.05 1.0 4.8 Time 0 Run 1 7 10.1 0.05 0.5 10.1
Time 0 Run 2 7 4.7 0.05 1.1 4.7 Time 0 Run 2 7 10.3 0.04 0.4 10.3
Time 0 Run 3 7 4.9 0.05 1.0 4.9 Time 0 Run 3 7 10.5 0.00 0.0 10.5
Baseline All 21 4.8 0.10 2.0 4.8 Baseline All 21 10.3 0.15 1.5 10.3
Month 01 7 4.8 0.05 1.0 4.8 Month 01 7 10.2 0.08 0.7 10.2
Month 02 7 4.8 0.00 0.0 4.8 Month 02 7 10.3 0.05 0.5 10.3
Month 03 7 4.8 0.04 0.8 4.8 Month 03 7 10.3 0.04 0.4 10.3
Month 04 7 4.8 0.00 0.0 4.8 Month 04 7 10.4 0.08 0.8 10.4
Month 05 7 4.8 0.00 0.0 4.8 Month 05 7 10.3 0.08 0.8 10.3
Month 06 7 5.1 0.04 0.7 5.1 Month 06 7 10.2 0.05 0.5 10.2
Month 07 7 4.8 0.00 0.0 4.8 Month 07 7 10.2 0.05 0.5 10.2
Month 08 7 4.8 0.00 0.0 4.8 Month 08 7 10.4 0.05 0.5 10.4
Month 09 7 4.8 0.00 0.0 4.8 Month 09 7 10.4 0.00 0.0 10.4
Month 10 7 4.8 0.05 1.1 4.8 Month 10 7 10.2 0.00 0.0 10.2
Month 11 7 4.7 0.05 1.0 4.7 Month 11 7 10.2 0.05 0.5 10.2
Month 12 7 4.8 0.00 0.0 4.8 Month 12 7 10.2 0.08 0.8 10.2
Month 13 7 4.8 0.00 0.0 4.8 Month 13 7 10.3 0.04 0.4 10.3
Month 14 7 4.8 0.05 1.1 4.8 Month 14 7 10.1 0.05 0.5 10.1
Month 15 7 4.8 0.00 0.0 4.8 Month 15 7 10.3 0.08 0.8 10.3
Crossover Month 15 7 4.7 0.04 0.8 4.7 Crossover Month 15 7 10.3 0.04 0.4 10.3
Month 16 7 4.7 0.00 0.0 4.8 Month 16 7 10.2 0.04 0.4 10.2
Adj = Adjusted

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Table III.A.1 (Continued)
Serum Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 4.8 0.05 1.0 4.8 Time 0 Run 1 7 10.1 0.05 0.5 10.1
Time 0 Run 2 7 4.8 0.05 1.1 4.8 Time 0 Run 2 7 10.3 0.05 0.5 10.3
Time 0 Run 3 7 4.9 0.00 0.0 4.9 Time 0 Run 3 7 10.4 0.08 0.7 10.4
Month 01 7 4.8 0.05 1.1 4.8 Month 01 7 10.2 0.05 0.5 10.2
Month 02 7 4.8 0.00 0.0 4.8 Month 02 7 10.3 0.04 0.4 10.3
Month 03 7 4.9 0.00 0.0 4.9 Month 03 7 10.2 0.05 0.5 10.2
Month 04 7 4.8 0.00 0.0 4.8 Month 04 7 10.3 0.00 0.0 10.3
Month 05 7 4.8 0.04 0.8 4.8 Month 05 7 10.2 0.13 1.3 10.2
Month 06 7 5.1 0.05 1.0 5.1 Month 06 7 10.2 0.04 0.4 10.2
Month 07 7 4.8 0.00 0.0 4.8 Month 07 7 10.1 0.08 0.8 10.1
Month 08 7 4.8 0.05 1.1 4.8 Month 08 7 10.4 0.05 0.5 10.4
Month 09 7 4.8 0.00 0.0 4.8 Month 09 7 10.3 0.04 0.4 10.3
Month 10 7 4.8 0.00 0.0 4.8 Month 10 7 10.2 0.05 0.5 10.2
Month 11 7 4.7 0.00 0.0 4.7 Month 11 7 10.2 0.07 0.7 10.2
Month 12 7 4.8 0.00 0.0 4.8 Month 12 7 10.3 0.05 0.5 10.3
Month 13 7 4.8 0.00 0.0 4.8 Month 13 7 10.2 0.05 0.5 10.2
Month 14 7 4.8 0.00 0.0 4.8 Month 14 7 10.0 0.13 1.3 10.0
Month 15 7 4.7 0.00 0.0 4.7 Month 15 7 10.3 0.04 0.4 10.3
Month 16 7 4.7 0.00 0.0 4.6 Month 16 7 10.1 0.13 1.2 9.8
Adj = Adjusted

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Serum Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 4.8 0.05 1.0 NA Time 0 Run 1 7 10.2 0.05 0.5 10.2
Baseline All 21 4.8 0.08 1.8 NA Baseline All 21 10.3 0.13 1.3 10.3
Month 01 7 4.9 0.05 1.0 NA Month 01 7 10.3 0.05 0.5 10.3
Month 02 7 4.8 0.00 0.0 NA Month 02 7 10.4 0.05 0.5 10.4
Month 03 7 4.8 0.00 0.0 NA Month 03 7 10.3 0.05 0.5 10.3
Month 04 7 4.9 0.05 1.1 NA Month 04 7 10.3 0.05 0.5 10.3
Month 05 7 4.8 0.05 1.0 NA Month 05 7 10.2 0.08 0.7 10.2
Month 06 7 4.8 0.04 0.8 NA Month 06 7 10.2 0.08 0.8 10.2
Month 07 7 4.8 0.00 0.0 NA Month 07 7 10.1 0.04 0.4 10.1
Month 08 7 4.8 0.04 0.8 NA Month 08 7 10.3 0.08 0.8 10.3
Month 09 7 4.8 0.00 0.0 NA Month 09 7 10.3 0.05 0.5 10.3
Month 10 7 4.8 0.04 0.8 NA Month 10 7 10.2 0.04 0.4 10.2
Month 11 7 4.7 0.00 0.0 NA Month 11 7 10.2 0.00 0.0 10.2
Month 12 7 4.8 0.04 0.8 NA Month 12 7 10.2 0.08 0.8 10.2
Month 13 7 4.8 0.00 0.0 NA Month 13 7 10.2 0.05 0.5 10.2
Month 14 7 4.7 0.00 0.0 NA Month 14 7 10.1 0.05 0.5 10.1
Month 15 7 4.7 0.00 0.0 NA Month 15 7 10.3 0.08 0.7 10.3
Crossover Month 15 7 4.7 0.00 0.0 NA Crossover Month 15 7 10.3 0.06 0.6 10.3
Month 16 7 4.7 0.00 0.0 NA Month 16 7 10.1 0.08 0.8 10.1
N/A = Not Applicable, Adj = Adjusted

ARCHITECT IRIS V1
Serum Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 4.8 0.04 0.8 4.8 Time 0 Run 1 7 10.1 0.08 0.8 10.1
Time 0 Run 2 7 4.8 0.00 0.0 4.8 Time 0 Run 2 7 10.2 0.08 0.7 10.2
Time 0 Run 3 7 4.9 0.00 0.0 4.9 Time 0 Run 3 7 10.5 0.05 0.5 10.5
Month 01 7 4.8 0.05 1.1 4.8 Month 01 7 10.2 0.05 0.5 10.2
Month 02 7 4.8 0.00 0.0 4.8 Month 02 7 10.4 0.00 0.0 10.4
Month 03 7 4.8 0.00 0.0 4.8 Month 03 7 10.2 0.04 0.4 10.2
Month 04 7 4.8 0.00 0.0 4.8 Month 04 7 10.3 0.00 0.0 10.3
Month 05 7 4.7 0.05 1.1 4.7 Month 05 7 10.2 0.08 0.7 10.2
Month 06 7 4.7 0.00 0.0 4.7 Month 06 7 10.2 0.05 0.5 10.2
Month 07 7 4.8 0.05 1.1 4.8 Month 07 7 10.1 0.14 1.4 10.1
Month 08 7 4.8 0.04 0.8 4.8 Month 08 7 10.3 0.06 0.6 10.3
Month 09 7 4.8 0.00 0.0 4.8 Month 09 7 10.3 0.04 0.4 10.3
Month 10 7 4.8 0.04 0.8 4.8 Month 10 7 10.2 0.04 0.4 10.2
Month 11 7 4.7 0.00 0.0 4.7 Month 11 7 10.2 0.05 0.5 10.2
Month 12 7 4.8 0.05 1.0 4.8 Month 12 7 10.3 0.08 0.7 10.3
Month 13 7 4.8 0.00 0.0 4.8 Month 13 7 10.2 0.05 0.5 10.2
Month 14 7 4.7 0.04 0.8 4.7 Month 14 7 10.0 0.08 0.8 10.0
Month 15 7 4.7 0.04 0.8 4.7 Month 15 7 10.3 0.05 0.5 10.3
Month 16 7 4.7 0.00 0.0 4.5 Month 16 7 10.2 0.04 0.4 10.1
Adj = Adjusted

ARCHITECT IRIS V1
Figure III.A.1
Serum Samples
Sample: Lyphochek Unassayed CC Level 1
BL= Baseline

ARCHITECT IRIS V1
Figure III.A.1 (Continued)
Serum Samples
BL= Baseline

ARCHITECT IRIS V1
Serum Samples
BL= Baseline

ARCHITECT IRIS V1
Serum Samples
BL= Baseline

ARCHITECT IRIS V1
Table III.A.2
Condition: Additional Intended Storage (IS)
Serum Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 18 4.8 0.05 1 4.8 Time 0 Run 1 18 9.8 0.05 0 9.8
Time 0 Run 2 18 4.9 0.02 0 4.9 Time 0 Run 2 18 9.8 0.07 1 9.8
Time 0 Run 3 18 4.9 0.02 0 4.9 Time 0 Run 3 18 9.9 0.06 1 9.9
Baseline All 54 4.9 0.06 1 4.9 Baseline All 54 9.8 0.06 1 9.8
Month 01 18 4.9 0.00 0 4.9 Month 01 18 10.0 0.05 1 10.0
Month 02 RUN 1 18 4.9 0.02 0 4.9 Month 02 RUN 1 18 9.8 0.03 0 9.8
Test Point 2 All 36 4.9 0.05 1 4.9 Test Point 2 All 36 9.8 0.02 0 9.8
Month 03 18 4.8 0.05 1 4.8 Month 03 18 9.8 0.03 0 9.8
Month 04 18 4.8 0.00 0 4.8 Month 04 18 9.7 0.05 1 9.7
Month 05 18 4.9 0.00 0 4.9 Month 05 18 9.9 0.02 0 9.9
Month 06 18 4.8 0.02 0 4.8 Month 06 18 9.9 0.04 0 9.9
Month 07 18 4.8 0.00 0 4.8 Month 07 18 9.8 0.03 0 9.8
Month 08 18 5.0 0.04 1 5.0 Month 08 18 9.9 0.06 1 9.9
Month 09 Run 1 18 4.9 0.05 1 4.9 Month 09 Run 1 18 9.8 0.05 0 9.8
Month 10 18 5.2 0.03 1 5.2 Month 10 18 10.7 0.05 0 10.7
Month 11 18 4.9 0.02 0 4.9 Month 11 18 9.9 0.05 1 9.9
Month 12 18 4.8 0.05 1 4.8 Month 12 18 9.9 0.05 1 9.9
Month 13 18 4.8 0.04 1 4.8 Month 13 18 9.9 0.03 0 9.9
Crossover Month 13 18 4.7 0.02 1 4.7 Crossover Month 13 18 10.2 0.06 1 10.2
Month 14 18 4.7 0.04 1 4.8 Month 14 18 10.2 0.03 0 9.9
Month 15 18 4.7 0.00 0 4.8 Month 15 18 10.2 0.03 0 9.9
Month 16 18 4.7 0.04 1 4.8 Month 16 18 10.1 0.03 0 9.8
Adj = Adjusted

ARCHITECT IRIS V1
Serum Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 18 4.8 0.00 0 4.8 Time 0 Run 1 18 9.8 0.05 0 9.8
Time 0 Run 2 18 4.9 0.04 1 4.9 Time 0 Run 2 18 9.9 0.05 0 9.9
Time 0 Run 3 18 4.8 0.05 1 4.8 Time 0 Run 3 18 9.8 0.10 1 9.8
Month 01 18 4.9 0.00 0 4.9 Month 01 18 10.0 0.05 1 10.0
Month 03 18 4.8 0.02 0 4.8 Month 03 18 10.1 0.06 1 10.1
Month 04 18 4.9 0.00 0 4.9 Month 04 18 9.8 0.06 1 9.8
Month 05 18 4.9 0.04 1 4.9 Month 05 18 9.8 0.05 0 9.8
Month 06 18 4.8 0.03 1 4.8 Month 06 18 9.8 0.06 1 9.8
Month 07 18 4.8 0.00 0 4.8 Month 07 18 9.8 0.03 0 9.8
Month 08 18 4.8 0.02 0 4.8 Month 08 18 9.8 0.05 0 9.8
Month 10 18 5.3 0.04 1 5.3 Month 10 18 10.7 0.04 0 10.7
Month 11 18 4.8 0.00 0 4.8 Month 11 18 9.8 0.06 1 9.8
Month 12 18 4.9 0.00 0 4.9 Month 12 18 9.8 0.05 1 9.8
Month 13 18 4.8 0.00 0 4.8 Month 13 18 9.9 0.05 0 9.9
Month 14 18 4.7 0.05 1 4.8 Month 14 18 10.2 0.02 0 9.9
Month 15 18 4.8 0.04 1 4.9 Month 15 18 10.2 0.04 0 9.9
Month 16 18 4.7 0.00 0 4.8 Month 16 18 10.1 0.03 0 9.8
Adj = Adjusted

ARCHITECT IRIS V1
Table III.A.3
Urine Samples
Sample: Liquichek Urine CC Level 1 Sample: Liquichek Urine CC Level 2

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 10.2 0.08 0.8 10.2 Time 0 Run 1 7 20.7 0.07 0.3 20.7
Time 0 Run 2 7 10.3 0.10 1.0 10.3 Time 0 Run 2 7 21.0 0.10 0.5 21.0
Time 0 Run 3 7 10.5 0.14 1.3 10.5 Time 0 Run 3 7 21.4 0.35 1.6 21.4
Month 01 7 10.0 0.14 1.4 10.0 Month 01 7 20.4 0.22 1.1 20.4
Month 02 7 10.3 0.17 1.7 10.3 Month 02 7 21.0 0.21 1.0 21.0
Month 03 7 10.2 0.13 1.3 10.2 Month 03 7 20.8 0.15 0.7 20.8
Month 04 7 10.2 0.12 1.1 10.2 Month 04 7 21.0 0.16 0.8 21.0
Month 05 7 10.1 0.08 0.7 10.1 Month 05 7 21.1 0.13 0.6 21.1
Month 06 7 10.0 0.10 1.0 10.0 Month 06 7 20.6 0.14 0.7 20.6
Month 07 7 10.4 0.07 0.7 10.4 Month 07 7 21.3 0.17 0.8 21.3
Month 08 7 10.1 0.11 1.1 10.1 Month 08 7 20.9 0.10 0.5 20.9
Month 09 7 10.1 0.10 0.9 10.1 Month 09 7 20.8 0.13 0.6 20.8
Month 10 7 10.0 0.17 1.7 10.0 Month 10 7 20.9 0.18 0.8 20.9
Month 11 7 9.9 0.09 0.9 9.9 Month 11 7 20.4 0.11 0.5 20.4
Month 12 7 9.9 0.28 2.8 9.9 Month 12 7 20.7 0.37 1.8 20.7
Month 13 7 10.2 0.05 0.5 10.2 Month 13 7 21.3 0.08 0.4 21.3
Month 14 7 9.8 0.11 1.2 9.8 Month 14 7 20.5 0.23 1.1 20.5
Month 15 7 9.8 0.13 1.4 9.8 Month 15 7 20.5 0.22 1.1 20.5
Month 16 7 9.3 0.12 1.3 9.9 Month 16 7 16.2 0.14 0.9 20.8
Adj = Adjusted

ARCHITECT IRIS V1
Urine Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 10.2 0.05 0.5 10.2 Time 0 Run 1 7 20.7 0.12 0.6 20.7
Time 0 Run 2 7 10.3 0.07 0.7 10.3 Time 0 Run 2 7 21.0 0.16 0.8 21.0
Time 0 Run 3 7 10.4 0.13 1.3 10.4 Time 0 Run 3 7 21.3 0.24 1.1 21.3
Month 01 7 10.1 0.13 1.3 10.1 Month 01 7 20.5 0.15 0.7 20.5
Month 02 7 10.0 0.14 1.4 10.0 Month 02 7 20.8 0.17 0.8 20.8
Month 03 7 10.3 0.08 0.7 10.3 Month 03 7 21.1 0.10 0.5 21.1
Month 04 7 10.2 0.16 1.5 10.2 Month 04 7 21.1 0.13 0.6 21.1
Month 05 7 10.2 0.13 1.3 10.2 Month 05 7 20.9 0.16 0.8 20.9
Month 06 7 10.0 0.07 0.7 10.0 Month 06 7 20.8 0.13 0.6 20.8
Month 07 7 10.2 0.07 0.7 10.2 Month 07 7 21.1 0.18 0.9 21.1
Month 08 7 10.0 0.06 0.6 10.0 Month 08 7 21.0 0.11 0.5 21.0
Month 09 7 10.0 0.09 0.9 10.0 Month 09 7 20.8 0.28 1.3 20.8
Month 10 7 10.2 0.15 1.5 10.2 Month 10 7 20.9 0.12 0.6 20.9
Month 11 7 9.8 0.09 0.9 9.8 Month 11 7 20.4 0.19 0.9 20.4
Month 12 7 9.9 0.17 1.7 9.9 Month 12 7 20.5 0.46 2.3 20.5
Month 13 7 10.2 0.10 1.0 10.2 Month 13 7 21.1 0.10 0.5 21.1
Month 14 7 9.9 0.15 1.5 9.9 Month 14 7 20.7 0.16 0.8 20.7
Month 15 7 9.6 0.05 0.6 9.6 Month 15 7 20.1 0.19 0.9 20.1
Month 16 7 9.3 0.08 0.9 9.6 Month 16 7 16.2 0.20 1.2 20.1
Adj = Adjusted

ARCHITECT IRIS V1
Urine Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 10.1 0.06 0.6 10.1 Time 0 Run 1 7 20.7 0.15 0.7 20.7
Time 0 Run 2 7 10.3 0.10 0.9 10.3 Time 0 Run 2 7 21.1 0.14 0.7 21.1
Time 0 Run 3 7 10.5 0.11 1.0 10.5 Time 0 Run 3 7 21.5 0.25 1.2 21.5
Month 01 7 10.1 0.17 1.7 10.1 Month 01 7 20.5 0.20 1.0 20.5
Month 02 7 10.2 0.12 1.1 10.2 Month 02 7 20.9 0.28 1.3 20.9
Month 03 7 10.0 0.14 1.4 10.0 Month 03 7 20.9 0.10 0.5 20.9
Month 04 7 10.3 0.00 0.0 10.3 Month 04 7 21.2 0.16 0.7 21.2
Month 05 7 10.1 0.04 0.4 10.1 Month 05 7 20.8 0.25 1.2 20.8
Month 06 7 10.0 0.06 0.6 10.0 Month 06 7 20.7 0.08 0.4 20.7
Month 07 7 10.2 0.08 0.7 10.2 Month 07 7 21.0 0.20 0.9 21.0
Month 08 7 10.0 0.08 0.8 10.0 Month 08 7 20.7 0.17 0.8 20.7
Month 09 7 10.0 0.15 1.5 10.0 Month 09 7 20.9 0.13 0.6 20.9
Month 10 7 10.2 0.10 1.0 10.2 Month 10 7 20.9 0.13 0.6 20.9
Month 11 7 9.9 0.08 0.8 9.9 Month 11 7 20.3 0.14 0.7 20.3
Month 12 7 9.8 0.20 2.0 9.8 Month 12 7 20.5 0.42 2.1 20.5
Month 13 7 10.1 0.09 0.9 10.1 Month 13 7 21.1 0.12 0.6 21.1
Month 14 7 9.7 0.15 1.6 9.7 Month 14 7 20.2 0.16 0.8 20.2
Month 15 7 9.6 0.16 1.6 9.6 Month 15 7 20.2 0.28 1.4 20.2
Month 16 7 9.3 0.08 0.8 9.8 Month 16 7 16.2 0.16 1.0 20.4
Adj = Adjusted

ARCHITECT IRIS V1
Urine Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 7 10.2 0.09 0.9 10.2 Time 0 Run 1 7 20.8 0.16 0.8 20.8
Time 0 Run 2 7 10.4 0.08 0.8 10.4 Time 0 Run 2 7 21.1 0.09 0.4 21.1
Time 0 Run 3 7 10.4 0.10 0.9 10.4 Time 0 Run 3 7 21.4 0.15 0.7 21.4
Month 01 7 10.0 0.11 1.1 10.0 Month 01 7 20.7 0.17 0.8 20.7
Month 02 7 10.1 0.10 0.9 10.1 Month 02 7 20.8 0.25 1.2 20.8
Month 03 7 10.2 0.10 0.9 10.2 Month 03 7 20.8 0.15 0.7 20.8
Month 04 7 10.2 0.12 1.2 10.2 Month 04 7 21.0 0.15 0.7 21.0
Month 05 7 10.1 0.13 1.3 10.1 Month 05 7 20.6 0.20 0.9 20.6
Month 06 7 10.1 0.10 0.9 10.1 Month 06 7 20.7 0.18 0.9 20.7
Month 07 7 10.1 0.08 0.8 10.1 Month 07 7 20.9 0.13 0.6 20.9
Month 08 7 10.0 0.05 0.5 10.0 Month 08 7 20.8 0.08 0.4 20.8
Month 09 7 9.9 0.05 0.5 9.9 Month 09 7 20.7 0.24 1.1 20.7
Month 10 7 10.1 0.13 1.3 10.1 Month 10 7 20.9 0.10 0.5 20.9
Month 11 7 9.7 0.07 0.7 9.7 Month 11 7 20.2 0.16 0.8 20.2
Month 12 7 9.8 0.22 2.3 9.8 Month 12 7 20.5 0.37 1.8 20.5
Month 13 7 10.2 0.08 0.8 10.2 Month 13 7 21.1 0.07 0.3 21.1
Month 14 7 9.6 0.15 1.6 9.6 Month 14 7 20.3 0.10 0.5 20.3
Month 15 7 9.5 0.11 1.2 9.5 Month 15 7 20.0 0.35 1.7 20.0
Month 16 7 9.3 0.10 1.0 9.5 Month 16 7 16.1 0.11 0.7 19.9
Adj = Adjusted

ARCHITECT IRIS V1
Figure III.A.2
Urine Samples
Sample: Liquichek Urine CC Level 1
BL= Baseline and C= Crossover

ARCHITECT IRIS V1
Figure III.A.2 Continued)
Urine Samples

ARCHITECT IRIS V1
Urine Samples

ARCHITECT IRIS V1
Urine Samples

ARCHITECT IRIS V1
Table III.A.4
Urine Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 18 9.0 0.14 2 9.0 Time 0 Run 1 18 15.8 0.15 1 15.8
Time 0 Run 2 18 9.0 0.13 1 9.0 Time 0 Run 2 18 16.0 0.16 1 16.0
Time 0 Run 3 18 9.3 0.09 1 9.3 Time 0 Run 3 18 16.6 0.13 1 16.6
Month 01 18 9.7 0.11 1 9.7 Month 01 18 17.3 0.15 1 17.3
Month 03 18 9.0 0.12 1 9.0 Month 03 18 16.2 0.20 1 16.2
Month 04 18 8.9 0.10 1 8.9 Month 04 18 15.9 0.15 1 15.9
Month 05 18 9.1 0.06 1 9.1 Month 05 18 16.3 0.12 1 16.3
Month 06 18 9.0 0.10 1 9.0 Month 06 18 16.2 0.14 1 16.2
Month 07 18 9.2 0.10 1 9.2 Month 07 18 16.2 0.12 1 16.2
Month 08 18 9.2 0.07 1 9.2 Month 08 18 16.4 0.15 1 16.4
Month 09 18 9.0 0.10 1 9.0 Month 09 18 16.1 0.17 1 16.1
Month 10 20 9.6 0.13 1 9.7 Month 10 20 24.3 0.18 1 17.9
Month 11 18 9.0 0.09 1 9.1 Month 11 18 22.8 0.16 1 16.4
Month 12 18 8.9 0.10 1 8.9 Month 12 18 22.3 0.18 1 15.9
Month 13 18 9.0 0.13 1 9.1 Month 13 18 22.6 0.19 1 16.2
Month 14 18 8.9 0.07 1 9.0 Month 14 18 22.1 0.18 1 15.6
Month 15 18 8.8 0.11 1 8.9 Month 15 18 22.4 0.18 1 16.0
Month 16 18 8.9 0.09 1 9.0 Month 16 18 22.3 0.13 1 15.9
Adj = Adjusted

ARCHITECT IRIS V1
Urine Samples

Adj. Adj.
Test Test
Test Test
(mg/dL (mg/dL
) )
) )
Time 0 Run 1 18 9.0 0.12 1 9.0 Time 0 Run 1 18 15.9 0.18 1 15.9
Time 0 Run 2 18 9.0 0.13 1 9.0 Time 0 Run 2 18 16.0 0.19 1 16.0
Time 0 Run 3 18 9.3 0.08 1 9.3 Time 0 Run 3 18 16.3 0.13 1 16.3
Month 01 18 9.6 0.11 1 9.6 Month 01 18 17.0 0.16 1 17.0
Month 03 18 9.0 0.11 1 9.0 Month 03 18 16.1 0.16 1 16.1
Month 04 18 9.1 0.07 1 9.1 Month 04 18 16.2 0.09 1 16.2
Month 05 18 8.9 0.09 1 8.9 Month 05 18 16.0 0.10 1 16.0
Month 06 18 9.0 0.07 1 9.0 Month 06 18 16.2 0.07 0 16.2
Month 07 18 9.0 0.08 1 9.0 Month 07 18 16.0 0.15 1 16.0
Month 08 18 8.7 0.06 1 8.7 Month 08 18 15.8 0.10 1 15.8
Month 09 18 8.8 0.07 1 8.8 Month 09 18 15.7 0.16 1 15.7
Month 10 20 9.7 0.10 1 9.5 Month 10 20 24.4 0.33 1 17.4
Month 11 18 8.9 0.07 1 8.7 Month 11 18 22.5 0.16 1 15.5
Month 12 18 8.9 0.09 1 8.7 Month 12 18 22.6 0.23 1 15.5
Month 13 18 8.9 0.06 1 8.7 Month 13 18 22.3 0.19 1 15.3
Month 14 18 8.7 0.08 1 8.5 Month 14 18 21.9 0.15 1 14.9
Month 15 18 8.9 0.11 1 8.7 Month 15 18 22.4 0.17 1 15.4
Month 16 18 8.9 0.06 1 8.7 Month 16 18 22.4 0.17 1 15.3
Adj = Adjusted

ARCHITECT IRIS V1
Table III.A.5
Condition: In-Use (IU)
Serum Samples

Test Test
Test Point Test Point
) )
Time 0 Run 1 7 4.8 0.05 1.0 Time 0 Run 1 7 10.1 0.05 0.5
Time 0 Run 2 7 4.7 0.05 1.1 Time 0 Run 2 7 10.3 0.04 0.4
Time 0 Run 3 7 4.9 0.05 1.0 Time 0 Run 3 7 10.5 0.00 0.0
Baseline All 21 4.8 0.10 2.0 Baseline All 21 10.3 0.15 1.5
Month 03 7 4.7 0.00 0.0 Month 03 7 10.2 0.05 0.5
Month 06 7 4.7 0.00 0.0 Month 06 7 10.3 0.05 0.5
Month 09 7 4.7 0.00 0.0 Month 09 7 10.4 0.04 0.4
Month 12 7 4.9 0.04 0.8 Month 12 7 10.1 0.05 0.5
Month 15 7 4.8 0.04 0.8 Month 15 7 10.4 0.00 0.0
Adj = Adjusted

ARCHITECT IRIS V1
Figure III.A.3
Serum Samples
BL= Baseline

ARCHITECT IRIS V1
Table III.A.6
Urine Samples

Test Test
Test Point Test Point
) )
Time 0 Run 1 7 10.2 0.08 0.8 Time 0 Run 1 7 20.7 0.07 0.3
Time 0 Run 2 7 10.3 0.10 1.0 Time 0 Run 2 7 21.0 0.10 0.5
Time 0 Run 3 7 10.5 0.14 1.3 Time 0 Run 3 7 21.4 0.35 1.6
Baseline All 21 10.4 0.16 1.6 Baseline All 21 21.0 0.35 1.6
Month 03 7 10.2 0.22 2.2 Month 03 7 20.8 0.25 1.2
Month 06 7 10.4 0.11 1.0 Month 06 7 21.5 0.08 0.4
Month 09 7 10.2 0.09 0.9 Month 09 7 21.2 0.14 0.7
Month 12 7 9.6 0.08 0.8 Month 12 7 20.3 0.10 0.5
Month 15 7 10.1 0.11 1.1 Month 15 7 21.1 0.23 1.1
Adj = Adjusted

ARCHITECT IRIS V1
Figure III.A.4
Urine Samples
BL= Baseline

ARCHITECT IRIS V1
Table III.A.7
Condition: Inverted Storage (INV)
Serum Samples

Test Test
Test Test Test Test Test Test
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Time 0 Run 1 7 4.8 0.04 1 Time 0 Run 1 7 10.1 0.08 1
Time 0 Run 2 7 4.8 0.00 0 Time 0 Run 2 7 10.2 0.08 1
Time 0 Run 3 7 4.9 0.00 0 Time 0 Run 3 7 10.5 0.05 1
Baseline All 21 4.8 0.06 1 Baseline All 21 10.3 0.17 2
Month 03 7 4.8 0.05 1 Month 03 7 10.2 0.05 1
Month 06 7 4.7 0.05 1 Month 06 7 10.6 0.05 1
Month 09 7 4.8 0.05 1 Month 09 7 10.3 0.08 1
Month 12 7 4.8 0.00 0 Month 12 7 10.3 0.04 0
Month 15 7 4.8 0.04 1 Month 15 7 10.4 0.08 1

ARCHITECT IRIS V1
Figure III.A.5
Serum Samples
BL= Baseline

ARCHITECT IRIS V1
Table III.A.8
Urine Samples

Test Test
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Time 0 Run 1 7 10.2 0.09 1 Time 0 Run 1 7 20.8 0.16 1
Time 0 Run 2 7 10.4 0.08 1 Time 0 Run 2 7 21.1 0.09 0
Time 0 Run 3 7 10.4 0.10 1 Time 0 Run 3 7 21.4 0.15 1
Month 03 7 10.2 0.15 1 Month 03 7 21.1 0.38 2
Month 06 7 10.3 0.14 1 Month 06 7 21.1 0.29 1
Month 09 7 9.9 0.12 1 Month 09 7 20.6 0.37 2
Month 12 7 9.7 0.16 2 Month 12 7 20.4 0.24 1
Month 15 7 9.6 0.05 1 Month 15 7 20.2 0.18 1

ARCHITECT IRIS V1
Figure III.A.6
Urine Samples
BL= Baseline

ARCHITECT IRIS V1
Table III.A.9
Condition: POEL
Serum Samples
Test Test
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Time 0 Run 1 7 4.8 0.04 1 Time 0 Run 1 7 10.1 0.08 1
Time 0 Run 2 7 4.8 0.00 0 Time 0 Run 2 7 10.2 0.08 1
Time 0 Run 3 7 4.9 0.00 0 Time 0 Run 3 7 10.5 0.05 1
POEL 7 4.8 0.05 1 POEL 7 10.3 0.05 1

ARCHITECT IRIS V1
Figure III.A.7
Condition: POEL
Serum Samples
BL= Baseline

ARCHITECT IRIS V1
Table III.A.10
Condition: POEL
Urine Samples
Test Test
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Time 0 Run 1 7 10.2 0.09 1 Time 0 Run 1 7 20.8 0.16 1

Time 0 Run 2 7 10.4 0.08 1 Time 0 Run 2 7 21.1 0.09 0
Time 0 Run 3 7 10.4 0.10 1 Time 0 Run 3 7 21.4 0.15 1
POEL 7 10.0 0.12 1 POEL 7 20.6 0.13 1

ARCHITECT IRIS V1
Figure III.A.8
Condition: POEL
Urine Samples
BL= Baseline

ARCHITECT IRIS V1
Table III.A.11
Condition: Transport Temperature Simulation (Transport)
Serum Samples

Test Test
Test Point Sub Test Point Mean Test Point Sub Test Point Mean
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Reference Unstressed 7 4.8 0.05 1 Reference Unstressed 7 10.4 0.05 1
Month 03 Month 03
Transport Stress 1 7 4.8 0.05 1 Transport Stress 1 7 10.3 0.04 0
Month 06 Month 06
Month 09 Month 09
Month 12 Transport Stress 1 7 4.7 0.05 1 Month 12 Transport Stress 1 7 10.3 0.05 1

ARCHITECT IRIS V1
Figure III.A.9
Serum Samples

ARCHITECT IRIS V1
Table III.A.12
Urine Samples

Test Test
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Month 03 Month 03
Month 06 Month 06
Month 09 Month 09

Reference Unstressed 7 16.4 0.10 1
Reference Unstressed 7 9.5 0.05 1
Month 15 Transport Stress 1 7 16.3 0.08 0
Month 15 Transport Stress 1 7 9.4 0.05 1
Transport Stress 3 7 16.5 0.08 0
Transport Stress 3 7 9.4 0.09 1

ARCHITECT IRIS V1
Figure III.A.10
Urine Samples

ARCHITECT IRIS V1
Table III.A.13
Condition: Transport Temperature Simulation + On Board Storage
(Transport + OBS)
Serum Samples

Test Test
Test Test Mean Test Test Test Test Mean Test Test
Sub Test Point Sub Test Point
Point N (mg/dL SD %CV Point N (mg/dL SD %CV
) )
Day 0 Transport OBS Day 0 Transport OBS
7 4.8 0.04 1 7 10.2 0.04 0
Reference Reference
7 4.7 0.00 0 7 10.2 0.05 0
Stress 1 Stress 1
7 4.7 0.00 0 7 10.2 0.05 1
Stress 2 Stress 2
Month 12 7 4.7 0.04 1 Month 12 7 10.2 0.05 1
Stress 1 Stress 1
7 4.8 0.04 1 7 10.4 0.00 0
Stress 2 Stress 2
7 4.6 0.04 1 7 10.1 0.00 0
Stress 1 Stress 1
7 4.8 0.00 0 7 10.3 0.05 0
Stress 2 Stress 2
7 4.7 0.00 0 7 10.3 0.05 1
Reference Reference
7 4.7 0.04 1 7 10.2 0.04 0
Stress 1 Stress 1
7 4.7 0.00 0 7 10.2 0.04 0
Stress 3 Stress 3
Month 15 7 4.6 0.04 1 Month 15 7 10.0 0.00 0
Stress 1 Stress 1
7 4.7 0.00 0 7 10.2 0.04 0
Stress 3 Stress 3
7 4.4 0.05 1 7 10.2 0.00 0
Stress 1 Stress 1
7 4.6 0.00 0 7 10.4 0.04 0
Stress 3 Stress 3

ARCHITECT IRIS V1
Figure III.A.11
(Transport + OBS)
Serum Samples

ARCHITECT IRIS V1
Table III.A.14
(Transport + OBS)
Urine Samples

Test Test
Test Test Mean Test Test Test Test Mean Test Test
Sub Test Point Sub Test Point
Point N (mg/dL SD %CV Point N (mg/dL SD %CV
) )
7 10.0 0.05 0 7 20.9 0.17 1
Reference Reference
7 9.9 0.08 1 7 20.7 0.14 1
Stress 1 Stress 1
7 9.7 0.12 1 7 20.6 0.20 1
Stress 2 Stress 2
Month 12 7 9.8 0.08 1 Month 12 7 20.7 0.17 1
Stress 1 Stress 1
7 10.0 0.08 1 7 21.1 0.08 0
Stress 2 Stress 2
7 9.5 0.08 1 7 20.2 0.21 1
Stress 1 Stress 1
7 9.8 0.12 1 7 20.8 0.14 1
Stress 2 Stress 2
7 9.4 0.05 1 7 16.3 0.05 0
Reference Reference
7 9.2 0.08 1 7 16.1 0.16 1
Stress 1 Stress 1
7 9.1 0.05 1 7 16.2 0.12 1
Stress 3 Stress 3
Month 15 7 9.2 0.05 1 Month 15 7 16.0 0.11 1
Stress 1 Stress 1
7 9.4 0.05 1 7 16.6 0.08 0
Stress 3 Stress 3
7 9.2 0.13 1 7 16.1 0.08 0
Stress 1 Stress 1
7 9.6 0.08 1 7 16.5 0.10 1
Stress 3 Stress 3

ARCHITECT IRIS V1
Figure III.A.12
(Transport + OBS)
Urine Samples

ARCHITECT IRIS V1
Table III.A.15
Condition: On Board Storage (OBS)
Serum Samples

Test Test
Test Point Sub Test Point Test Point Sub Test Point
) )
Day 0 7 4.7 0.00 0 Day 0 7 10.2 0.05 0
Month 02 OBS Day 15 7 4.7 0.00 0 Month 02 OBS Day 15 7 10.0 0.05 0
Day 31 7 4.8 0.05 1 Day 31 7 10.4 0.00 0
Day 0 7 4.7 0.05 1 Day 0 7 10.3 0.04 0
Day 31 7 4.7 0.05 1 Day 31 7 10.2 0.00 0
Day 0 7 4.7 0.04 1 Day 0 7 10.3 0.04 0
Day 31 7 4.7 0.05 1 Day 31 7 10.3 0.04 0

ARCHITECT IRIS V1
Serum Samples
Sample: Lyphochek Unassayed CC Level 1 Sample: Lyphochek Unassayed Level 2

Test Test
) )
Day 0 7 4.7 0.00 0 Day 0 7 10.2 0.04 0
Day 31 7 4.7 0.00 0 Day 31 7 10.3 0.04 0
Day 0 7 4.8 0.05 1 Day 0 7 10.2 0.05 1
Day 31 7 4.7 0.05 1 Day 31 7 10.2 0.00 0
Day 0 7 4.7 0.05 1 Day 0 7 10.3 0.00 0
Day 31 7 4.7 0.00 0 Day 31 7 10.3 0.00 0

ARCHITECT IRIS V1
Serum Samples

Test Test
) )
Day 0 7 4.7 0.00 0 Day 0 7 10.2 0.04 0
Day 31 7 4.7 0.04 1 Day 31 7 10.3 0.00 0
Day 0 7 4.8 0.04 1 Day 0 7 10.2 0.04 0
Day 31 7 4.8 0.05 1 Day 31 7 10.1 0.04 0
Day 0 7 4.7 0.04 1 Day 0 7 10.3 0.08 1
Day 31 7 4.7 0.00 0 Day 31 7 10.2 0.05 0

ARCHITECT IRIS V1
Serum Samples

Test Test
) )
Day 0 7 4.7 0.04 1 Day 0 7 10.2 0.00 0
Day 31 7 4.8 0.08 2 Day 31 7 10.6 0.04 0
Day 0 7 4.7 0.00 0 Day 0 7 10.2 0.04 0
Day 31 7 4.7 0.00 0 Day 31 7 10.2 0.05 1
Day 0 7 4.7 0.05 1 Day 0 7 10.3 0.05 0
Day 31 7 4.7 0.04 1 Day 31 7 10.3 0.00 0

ARCHITECT IRIS V1
Figure III.A.13
Serum Samples

ARCHITECT IRIS V1
Serum Samples

ARCHITECT IRIS V1
Serum Samples

ARCHITECT IRIS V1
Serum Samples

ARCHITECT IRIS V1
Table III.A.16
Condition: Additional On Board Storage (OBS)
Serum Samples

Test Test
) )
Day 0 18 4.8 0.05 1 Day 0 18 9.9 0.05 1
Day 31 18 4.6 0.03 1 Day 31 18 9.6 0.02 0
Day 0 18 4.8 0.03 1 Day 0 18 9.8 0.05 1
Day 31 18 4.7 0.00 0 Day 31 18 9.7 0.02 0
Day 0 18 4.8 0.00 0 Day 0 18 9.8 0.04 0
Day 31 18 4.7 0.00 0 Day 31 18 9.6 0.04 0
Day 0 18 4.8 0.05 1 Day 0 18 9.8 0.05 0
Day 31 18 4.9 0.04 1 Day 31 18 9.9 0.02 0
Day 0 18 4.8 0.00 0 Day 0 18 10.1 0.08 1
Day 31 18 4.7 0.00 0 Day 31 18 10.0 0.00 0

ARCHITECT IRIS V1
Serum Samples

Test Test
) )
Day 0 18 4.8 0.00 0 Day 0 18 9.8 0.05 1
Day 31 18 4.6 0.04 1 Day 31 18 9.6 0.05 1
Day 0 18 4.8 0.02 0 Day 0 18 9.9 0.05 0
Day 31 18 4.8 0.05 1 Day 31 18 9.7 0.05 1
Day 0 18 4.8 0.00 0 Day 0 18 9.9 0.05 1
Day 31 18 4.7 0.04 1 Day 31 18 9.6 0.05 1
Day 0 18 4.8 0.05 1 Day 0 18 9.8 0.03 0
Day 31 18 4.8 0.03 1 Day 31 18 9.9 0.05 1
Day 0 18 4.7 0.05 1 Day 0 18 10.2 0.05 0
Day 31 18 4.6 0.00 0 Day 31 18 10.0 0.05 1

ARCHITECT IRIS V1
Table III.A.17
Urine Samples

Test Test
) )
Day 0 7 10.1 0.08 1 Day 0 7 20.8 0.16 1
Day 31 7 10.4 0.11 1 Day 31 7 21.2 0.09 0
Day 0 7 10.0 0.11 1 Day 0 7 20.7 0.18 1
Day 31 7 10.1 0.05 1 Day 31 7 20.8 0.08 0
Day 0 7 9.5 0.08 1 Day 0 7 16.6 0.11 1
Day 31 7 9.5 0.10 1 Day 31 7 16.6 0.10 1

ARCHITECT IRIS V1
Urine Samples

Test Test
) )
Day 0 7 10.0 0.08 1 Day 0 7 20.7 0.14 1
Day 31 7 10.2 0.12 1 Day 31 7 20.9 0.05 0
Day 0 7 10.0 0.08 1 Day 0 7 20.7 0.18 1
Day 31 7 10.2 0.10 1 Day 31 7 20.9 0.13 1
Day 0 7 9.5 0.08 1 Day 0 7 16.5 0.12 1
Day 31 7 9.5 0.12 1 Day 31 7 16.5 0.07 0

ARCHITECT IRIS V1
Urine Samples

Test Test
) )
Day 0 7 10.1 0.15 1 Day 0 7 20.7 0.18 1
Day 31 7 10.2 0.05 0 Day 31 7 21.0 0.08 0
Day 0 7 10.1 0.08 1 Day 0 7 20.8 0.17 1
Day 31 7 10.1 0.10 1 Day 31 7 20.8 0.15 1
Day 0 7 9.4 0.11 1 Day 0 7 16.4 0.10 1
Day 31 7 9.5 0.11 1 Day 31 7 16.6 0.08 0

ARCHITECT IRIS V1
Urine Samples

Test Test
) )
Day 0 7 10.0 0.12 1 Day 0 7 20.7 0.16 1
Day 31 7 10.4 0.04 0 Day 31 7 21.4 0.09 0
Day 0 7 9.9 0.10 1 Day 0 7 20.7 0.15 1
Day 31 7 10.1 0.12 1 Day 31 7 20.7 0.08 0
Day 0 7 9.5 0.09 1 Day 0 7 16.5 0.16 1
Day 31 7 9.6 0.00 0 Day 31 7 16.7 0.12 1

ARCHITECT IRIS V1
Figure III.A.14
Urine Samples

ARCHITECT IRIS V1
Urine Samples

ARCHITECT IRIS V1
Urine Samples

ARCHITECT IRIS V1
Urine Samples

ARCHITECT IRIS V1
Table III.A.18
Urine Samples

Test Test
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Day 0 18 9.1 0.08 1 Day 0 18 16.2 0.10 1
Day 31 18 8.8 0.09 1 Day 31 18 15.8 0.09 1
Day 0 18 8.9 0.11 1 Day 0 18 15.8 0.11 1
Day 31 18 8.8 0.06 1 Day 31 18 15.6 0.11 1
Day 0 18 9.2 0.10 1 Day 0 18 16.3 0.13 1
Day 31 18 8.9 0.19 2 Day 31 18 16.0 0.13 1
Day 0 18 9.2 0.11 1 Day 0 18 23.1 0.31 1
Day 31 18 9.4 0.08 1 Day 31 18 23.3 0.21 1
Day 0 18 9.3 0.07 1 Day 0 18 23.1 0.17 1
Day 31 18 9.0 0.08 1 Day 31 18 22.8 0.15 1

ARCHITECT IRIS V1
Urine Samples

Test Test
N SD %CV N SD %CV
(mg/dL) (mg/dL)
Day 0 18 9.0 0.08 1 Day 0 18 15.9 0.10 1
Day 31 18 8.6 0.08 1 Day 31 18 15.4 0.10 1
Day 0 18 8.9 0.07 1 Day 0 18 15.8 0.18 1
Day 31 18 8.9 0.08 1 Day 31 18 15.7 0.11 1
Day 0 18 9.1 0.09 1 Day 0 18 16.2 0.14 1
Day 31 18 8.9 0.09 1 Day 31 18 15.9 0.12 1
Day 0 18 9.0 0.10 1 Day 0 18 22.6 0.15 1
Day 31 18 9.1 0.08 1 Day 31 18 22.7 0.19 1
Day 0 18 9.0 0.09 1 Day 0 18 22.4 0.16 1
Day 31 18 8.7 0.08 1 Day 31 18 22.1 0.11 1

ARCHITECT IRIS V1
Table III.A.19
Shift and % Shift
Serum Samples
Shift % Shifta
Value One-Sided One-Sided
Baseline Value
Sample Slope Slope SE Month (mg/dL 95% CL 95% CL SE
Mean (mg/dL) (%)
) (Lower, Upper) (Lower, Upper)
1 0.0 (-0.1, 0.1) -0.1 (-1.3, 1.2) 0.08
2 0.0 (-0.1, 0.0) -0.1 (-1.3, 1.0) 0.17
3 0.0 (-0.1, 0.0) -0.2 (-1.3, 0.9) 0.25
4 0.0 (-0.1, 0.0) -0.3 (-1.2, 0.7) 0.33
5 0.0 (-0.1, 0.0) -0.3 (-1.2, 0.5) 0.42
6 0.0 (-0.1, 0.0) -0.4 (-1.2, 0.4) 0.50
7 0.0 (-0.1, 0.0) -0.5 (-1.2, 0.3) 0.58
8 0.0 (-0.1, 0.0) -0.5 (-1.3, 0.2) 0.67
Lyphochek Unassayed CC lvl 1 4.8 -0.0031 0.00401
9 0.0 (-0.1, 0.0) -0.6 (-1.3, 0.1) 0.75
10 0.0 (-0.1, 0.0) -0.7 (-1.4, 0.1) 0.83
11 0.0 (-0.1, 0.0) -0.7 (-1.6, 0.1) 0.92
12 0.0 (-0.1, 0.0) -0.8 (-1.7, 0.1) 1.00
13 0.0 (-0.1, 0.0) -0.9 (-1.9, 0.2) 1.08
14 0.0 (-0.1, 0.0) -0.9 (-2.0, 0.2) 1.17
15 0.0 (-0.1, 0.0) -1.0 (-2.2, 0.2) 1.25
16 -0.1 (-0.1, 0.0) -1.0 (-2.4, 0.3) 1.33
1 0.0 (-0.1, 0.1) -0.1 (-0.6, 0.5) 0.04
2 0.0 (-0.1, 0.0) -0.1 (-0.7, 0.4) 0.07
3 0.0 (-0.1, 0.0) -0.2 (-0.7, 0.2) 0.11
4 0.0 (-0.1, 0.0) -0.3 (-0.7, 0.1) 0.15
5 0.0 (-0.1, 0.0) -0.4 (-0.8, 0.0) 0.19
6 0.0 (-0.1, 0.0) -0.4 (-0.8, -0.1) 0.22
7 -0.1 (-0.1, 0.0) -0.5 (-0.9, -0.2) 0.26
8 -0.1 (-0.1, 0.0) -0.6 (-0.9, -0.3) 0.30
9 -0.1 (-0.1, 0.0) -0.7 (-1.0, -0.3) 0.33
10 -0.1 (-0.1, 0.0) -0.7 (-1.1, -0.4) 0.37
11 -0.1 (-0.1, 0.0) -0.8 (-1.2, -0.4) 0.41
12 -0.1 (-0.1, 0.0) -0.9 (-1.3, -0.5) 0.45
13 -0.1 (-0.1, -0.1) -1.0 (-1.4, -0.5) 0.48
14 -0.1 (-0.2, -0.1) -1.0 (-1.5, -0.5) 0.52
15 -0.1 (-0.2, -0.1) -1.1 (-1.7, -0.6) 0.56
16 -0.1 (-0.2, -0.1) -1.2 (-1.8, -0.6) 0.59
a
NA indicates the baseline is either missing or equals to 0.
Note: The independent variable of the regression model is month.

ARCHITECT IRIS V1
Shift and % Shift
Serum Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.1, 0.1) -0.2 (-1.5, 1.1) 0.08
2 0.0 (-0.1, 0.0) -0.4 (-1.6, 0.8) 0.17
3 0.0 (-0.1, 0.0) -0.6 (-1.6, 0.5) 0.25
4 0.0 (-0.1, 0.0) -0.8 (-1.7, 0.2) 0.34
5 0.0 (-0.1, 0.0) -1.0 (-1.8, -0.1) 0.42
6 -0.1 (-0.1, 0.0) -1.2 (-2.0, -0.3) 0.51
7 -0.1 (-0.1, 0.0) -1.3 (-2.1, -0.6) 0.59
8 -0.1 (-0.1, 0.0) -1.5 (-2.3, -0.8) 0.68
9 -0.1 (-0.1, 0.0) -1.7 (-2.5, -1.0) 0.76
10 -0.1 (-0.1, -0.1) -1.9 (-2.7, -1.1) 0.85
11 -0.1 (-0.1, -0.1) -2.1 (-3.0, -1.3) 0.93
12 -0.1 (-0.2, -0.1) -2.3 (-3.2, -1.4) 1.02
13 -0.1 (-0.2, -0.1) -2.5 (-3.5, -1.5) 1.10
14 -0.1 (-0.2, -0.1) -2.7 (-3.8, -1.6) 1.19
15 -0.1 (-0.2, -0.1) -2.9 (-4.1, -1.6) 1.27
16 -0.1 (-0.2, -0.1) -3.1 (-4.4, -1.7) 1.36
1 0.0 (-0.1, 0.1) -0.1 (-1.1, 0.9) 0.06
2 0.0 (-0.1, 0.1) -0.2 (-1.1, 0.7) 0.12
3 0.0 (-0.1, 0.0) -0.3 (-1.1, 0.5) 0.19
4 0.0 (-0.1, 0.0) -0.4 (-1.1, 0.3) 0.25
5 -0.1 (-0.1, 0.0) -0.5 (-1.2, 0.1) 0.31
6 -0.1 (-0.1, 0.0) -0.6 (-1.2, 0.0) 0.37
7 -0.1 (-0.1, 0.0) -0.7 (-1.3, -0.2) 0.43
8 -0.1 (-0.1, 0.0) -0.8 (-1.4, -0.3) 0.50
9 -0.1 (-0.2, 0.0) -0.9 (-1.5, -0.4) 0.56
10 -0.1 (-0.2, 0.0) -1.0 (-1.6, -0.5) 0.62
11 -0.1 (-0.2, -0.1) -1.1 (-1.8, -0.5) 0.68
12 -0.1 (-0.2, -0.1) -1.2 (-1.9, -0.6) 0.75
13 -0.1 (-0.2, -0.1) -1.3 (-2.1, -0.6) 0.81
14 -0.1 (-0.2, -0.1) -1.4 (-2.3, -0.6) 0.87
15 -0.2 (-0.3, -0.1) -1.5 (-2.5, -0.6) 0.93
16 -0.2 (-0.3, -0.1) -1.6 (-2.7, -0.6) 0.99
a

ARCHITECT IRIS V1
Shift and % Shift
Serum Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (0.0, 0.0) -0.2 (-0.7, 0.4) 0.03
2 0.0 (0.0, 0.0) -0.3 (-0.8, 0.1) 0.07
3 0.0 (0.0, 0.0) -0.5 (-0.9, -0.1) 0.10
4 0.0 (-0.1, 0.0) -0.7 (-1.1, -0.3) 0.14
5 0.0 (-0.1, 0.0) -0.8 (-1.2, -0.5) 0.17
6 0.0 (-0.1, 0.0) -1.0 (-1.3, -0.7) 0.21
7 -0.1 (-0.1, 0.0) -1.2 (-1.5, -0.9) 0.24
8 -0.1 (-0.1, 0.0) -1.3 (-1.6, -1.0) 0.27
9 -0.1 (-0.1, -0.1) -1.5 (-1.8, -1.2) 0.31
10 -0.1 (-0.1, -0.1) -1.7 (-2.0, -1.3) 0.34
11 -0.1 (-0.1, -0.1) -1.8 (-2.2, -1.5) 0.38
12 -0.1 (-0.1, -0.1) -2.0 (-2.4, -1.6) 0.41
13 -0.1 (-0.1, -0.1) -2.2 (-2.6, -1.7) 0.44
14 -0.1 (-0.1, -0.1) -2.3 (-2.8, -1.9) 0.48
15 -0.1 (-0.1, -0.1) -2.5 (-3.0, -2.0) 0.51
16 -0.1 (-0.2, -0.1) -2.7 (-3.2, -2.1) 0.55
1 0.0 (-0.1, 0.1) -0.1 (-0.7, 0.5) 0.04
2 0.0 (-0.1, 0.0) -0.2 (-0.7, 0.4) 0.07
3 0.0 (-0.1, 0.0) -0.3 (-0.7, 0.2) 0.11
4 0.0 (-0.1, 0.0) -0.3 (-0.8, 0.1) 0.15
5 0.0 (-0.1, 0.0) -0.4 (-0.8, 0.0) 0.19
6 -0.1 (-0.1, 0.0) -0.5 (-0.9, -0.2) 0.22
7 -0.1 (-0.1, 0.0) -0.6 (-0.9, -0.3) 0.26
8 -0.1 (-0.1, 0.0) -0.7 (-1.0, -0.4) 0.30
9 -0.1 (-0.1, 0.0) -0.8 (-1.1, -0.4) 0.33
10 -0.1 (-0.1, -0.1) -0.8 (-1.2, -0.5) 0.37
11 -0.1 (-0.1, -0.1) -0.9 (-1.3, -0.6) 0.41
12 -0.1 (-0.1, -0.1) -1.0 (-1.4, -0.6) 0.45
13 -0.1 (-0.2, -0.1) -1.1 (-1.6, -0.7) 0.48
14 -0.1 (-0.2, -0.1) -1.2 (-1.7, -0.7) 0.52
15 -0.1 (-0.2, -0.1) -1.3 (-1.8, -0.7) 0.56
16 -0.1 (-0.2, -0.1) -1.4 (-2.0, -0.8) 0.60
a

ARCHITECT IRIS V1
Shift and % Shift
Serum Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.1, 0.0) -0.2 (-1.1, 0.7) 0.06
2 0.0 (-0.1, 0.0) -0.4 (-1.2, 0.4) 0.12
3 0.0 (-0.1, 0.0) -0.6 (-1.4, 0.1) 0.18
4 0.0 (-0.1, 0.0) -0.8 (-1.5, -0.1) 0.24
5 0.0 (-0.1, 0.0) -1.0 (-1.6, -0.4) 0.30
6 -0.1 (-0.1, 0.0) -1.2 (-1.8, -0.6) 0.35
7 -0.1 (-0.1, 0.0) -1.4 (-1.9, -0.9) 0.41
8 -0.1 (-0.1, -0.1) -1.6 (-2.1, -1.1) 0.47
9 -0.1 (-0.1, -0.1) -1.8 (-2.3, -1.3) 0.53
10 -0.1 (-0.1, -0.1) -2.0 (-2.6, -1.5) 0.59
11 -0.1 (-0.1, -0.1) -2.2 (-2.8, -1.6) 0.65
12 -0.1 (-0.1, -0.1) -2.4 (-3.1, -1.8) 0.71
13 -0.1 (-0.2, -0.1) -2.6 (-3.3, -1.9) 0.77
14 -0.1 (-0.2, -0.1) -2.8 (-3.6, -2.0) 0.83
15 -0.1 (-0.2, -0.1) -3.0 (-3.9, -2.1) 0.89
16 -0.2 (-0.2, -0.1) -3.2 (-4.2, -2.3) 0.95
1 0.0 (-0.1, 0.1) -0.1 (-0.7, 0.5) 0.04
2 0.0 (-0.1, 0.0) -0.1 (-0.7, 0.4) 0.08
3 0.0 (-0.1, 0.0) -0.2 (-0.7, 0.3) 0.12
4 0.0 (-0.1, 0.0) -0.3 (-0.7, 0.2) 0.16
5 0.0 (-0.1, 0.0) -0.3 (-0.8, 0.1) 0.20
6 0.0 (-0.1, 0.0) -0.4 (-0.8, 0.0) 0.24
7 0.0 (-0.1, 0.0) -0.5 (-0.8, -0.1) 0.28
8 -0.1 (-0.1, 0.0) -0.5 (-0.9, -0.2) 0.32
9 -0.1 (-0.1, 0.0) -0.6 (-1.0, -0.3) 0.36
10 -0.1 (-0.1, 0.0) -0.7 (-1.1, -0.3) 0.39
11 -0.1 (-0.1, 0.0) -0.8 (-1.1, -0.4) 0.43
12 -0.1 (-0.1, 0.0) -0.8 (-1.3, -0.4) 0.47
13 -0.1 (-0.1, 0.0) -0.9 (-1.4, -0.4) 0.51
14 -0.1 (-0.2, 0.0) -1.0 (-1.5, -0.4) 0.55
15 -0.1 (-0.2, 0.0) -1.0 (-1.6, -0.4) 0.59
16 -0.1 (-0.2, 0.0) -1.1 (-1.7, -0.5) 0.63
a

ARCHITECT IRIS V1
Table III.A.20
Shift and % Shift
Serum Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.1, 0.1) -0 (-2, 2) 0.1
2 0.0 (-0.1, 0.1) -0 (-2, 1) 0.2
3 0.0 (-0.1, 0.1) -0 (-1, 1) 0.3
4 0.0 (-0.1, 0.1) -0 (-1, 1) 0.4
5 0.0 (-0.1, 0.0) -0 (-1, 1) 0.5
6 0.0 (-0.1, 0.0) -0 (-1, 1) 0.6
7 0.0 (-0.1, 0.0) -0 (-1, 1) 0.7
8 0.0 (-0.1, 0.0) -0 (-1, 1) 0.8
9 0.0 (-0.1, 0.0) -0 (-1, 1) 1.0
10 0.0 (-0.1, 0.0) -0 (-1, 1) 1.1
11 0.0 (-0.1, 0.0) -0 (-2, 1) 1.2
12 0.0 (-0.1, 0.0) -0 (-2, 1) 1.3
13 0.0 (-0.1, 0.0) -1 (-2, 1) 1.4
14 0.0 (-0.1, 0.0) -1 (-2, 1) 1.5
15 0.0 (-0.1, 0.0) -1 (-2, 1) 1.6
16 0.0 (-0.1, 0.1) -1 (-2, 1) 1.7
1 0.0 (-0.1, 0.2) 0 (-2, 2) 0.1
2 0.0 (-0.1, 0.2) 0 (-1, 2) 0.2
3 0.0 (-0.1, 0.2) 0 (-1, 2) 0.3
4 0.0 (-0.1, 0.1) 0 (-1, 1) 0.4
5 0.0 (-0.1, 0.1) 0 (-1, 1) 0.5
6 0.0 (-0.1, 0.1) 0 (-1, 1) 0.6
7 0.1 (0.0, 0.1) 1 (0, 1) 0.7
8 0.1 (0.0, 0.1) 1 (0, 2) 0.8
Lyphochek Unassayed CC lvl 2 9.8 0.0073 0.01022
9 0.1 (0.0, 0.2) 1 (0, 2) 0.9
10 0.1 (0.0, 0.2) 1 (0, 2) 1.0
11 0.1 (0.0, 0.2) 1 (0, 2) 1.1
12 0.1 (0.0, 0.2) 1 (0, 2) 1.2
13 0.1 (0.0, 0.2) 1 (0, 2) 1.3
14 0.1 (0.0, 0.2) 1 (0, 2) 1.5
15 0.1 (0.0, 0.3) 1 (0, 3) 1.6
16 0.1 (0.0, 0.3) 1 (-1, 3) 1.7
a

ARCHITECT IRIS V1
Shift and % Shift
Serum Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.1, 0.1) 0 (-2, 2) 0.1
2 0.0 (-0.1, 0.1) 0 (-2, 2) 0.2
3 0.0 (-0.1, 0.1) 0 (-1, 2) 0.4
4 0.0 (-0.1, 0.1) 0 (-1, 1) 0.5
5 0.0 (-0.1, 0.1) 0 (-1, 1) 0.6
6 0.0 (-0.1, 0.1) 0 (-1, 1) 0.7
7 0.0 (0.0, 0.1) 0 (-1, 1) 0.8
8 0.0 (0.0, 0.1) 0 (-1, 1) 1.0
9 0.0 (0.0, 0.1) 0 (-1, 1) 1.1
10 0.0 (0.0, 0.1) 0 (-1, 1) 1.2
11 0.0 (-0.1, 0.1) 0 (-1, 1) 1.3
12 0.0 (-0.1, 0.1) 0 (-1, 1) 1.4
13 0.0 (-0.1, 0.1) 0 (-1, 2) 1.5
14 0.0 (-0.1, 0.1) 0 (-1, 2) 1.7
15 0.0 (-0.1, 0.1) 0 (-2, 2) 1.8
16 0.0 (-0.1, 0.1) 0 (-2, 2) 1.9
1 0.0 (-0.2, 0.2) 0 (-2, 2) 0.1
2 0.0 (-0.1, 0.2) 0 (-1, 2) 0.2
3 0.0 (-0.1, 0.1) 0 (-1, 1) 0.3
4 0.0 (-0.1, 0.1) 0 (-1, 1) 0.4
5 0.0 (-0.1, 0.1) 0 (-1, 1) 0.6
6 0.0 (-0.1, 0.1) 0 (-1, 1) 0.7
7 0.0 (-0.1, 0.1) 0 (-1, 1) 0.8
8 0.0 (-0.1, 0.1) 0 (-1, 1) 0.9
9 0.0 (-0.1, 0.1) 0 (-1, 1) 1.0
10 0.0 (-0.1, 0.1) 0 (-1, 1) 1.1
11 0.0 (-0.1, 0.1) 0 (-1, 1) 1.2
12 0.0 (-0.1, 0.2) 0 (-1, 2) 1.3
13 0.0 (-0.1, 0.2) 0 (-1, 2) 1.4
14 0.0 (-0.1, 0.2) 0 (-1, 2) 1.6
15 0.0 (-0.1, 0.2) 0 (-1, 2) 1.7
16 0.0 (-0.1, 0.2) 0 (-1, 2) 1.8
a

ARCHITECT IRIS V1
Table III.A.21
Shift and % Shift
Urine Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.1, 0.1) -0.2 (-1.1, 0.6) 0.06
2 0.0 (-0.1, 0.0) -0.4 (-1.2, 0.3) 0.11
3 -0.1 (-0.1, 0.0) -0.7 (-1.4, 0.0) 0.17
4 -0.1 (-0.2, 0.0) -0.9 (-1.5, -0.2) 0.23
5 -0.1 (-0.2, -0.1) -1.1 (-1.7, -0.5) 0.28
6 -0.1 (-0.2, -0.1) -1.3 (-1.9, -0.8) 0.34
7 -0.2 (-0.2, -0.1) -1.6 (-2.1, -1.1) 0.40
8 -0.2 (-0.2, -0.1) -1.8 (-2.3, -1.3) 0.45
Liquichek Urine CC ctrl lvl 1 10.4 -0.0232 0.00587
9 -0.2 (-0.3, -0.2) -2.0 (-2.5, -1.5) 0.51
10 -0.2 (-0.3, -0.2) -2.2 (-2.8, -1.7) 0.57
11 -0.3 (-0.3, -0.2) -2.5 (-3.0, -1.9) 0.62
12 -0.3 (-0.3, -0.2) -2.7 (-3.3, -2.1) 0.68
13 -0.3 (-0.4, -0.2) -2.9 (-3.6, -2.2) 0.74
14 -0.3 (-0.4, -0.2) -3.1 (-3.9, -2.4) 0.79
15 -0.3 (-0.4, -0.3) -3.4 (-4.2, -2.5) 0.85
16 -0.4 (-0.5, -0.3) -3.6 (-4.5, -2.7) 0.91
1 0.0 (-0.2, 0.2) -0.1 (-1.0, 0.9) 0.06
2 0.0 (-0.2, 0.2) -0.1 (-1.0, 0.8) 0.13
3 0.0 (-0.2, 0.1) -0.2 (-1.0, 0.6) 0.19
4 0.0 (-0.2, 0.1) -0.2 (-1.0, 0.5) 0.26
5 -0.1 (-0.2, 0.1) -0.3 (-0.9, 0.4) 0.32
6 -0.1 (-0.2, 0.1) -0.3 (-0.9, 0.3) 0.38
7 -0.1 (-0.2, 0.0) -0.4 (-1.0, 0.2) 0.45
8 -0.1 (-0.2, 0.0) -0.4 (-1.0, 0.1) 0.51
9 -0.1 (-0.2, 0.0) -0.5 (-1.1, 0.1) 0.58
10 -0.1 (-0.2, 0.0) -0.5 (-1.1, 0.0) 0.64
11 -0.1 (-0.3, 0.0) -0.6 (-1.2, 0.0) 0.70
12 -0.1 (-0.3, 0.0) -0.7 (-1.4, 0.0) 0.77
13 -0.1 (-0.3, 0.0) -0.7 (-1.5, 0.1) 0.83
14 -0.2 (-0.3, 0.0) -0.8 (-1.6, 0.1) 0.90
15 -0.2 (-0.4, 0.0) -0.8 (-1.8, 0.1) 0.96
16 -0.2 (-0.4, 0.0) -0.9 (-1.9, 0.2) 1.02
a

ARCHITECT IRIS V1
Shift and % Shift
Urine Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.2, 0.1) -0.3 (-1.5, 1.0) 0.08
2 -0.1 (-0.2, 0.1) -0.5 (-1.7, 0.6) 0.16
3 -0.1 (-0.2, 0.0) -0.8 (-1.8, 0.2) 0.24
4 -0.1 (-0.2, 0.0) -1.1 (-2.0, -0.2) 0.32
5 -0.1 (-0.2, -0.1) -1.4 (-2.2, -0.5) 0.40
6 -0.2 (-0.2, -0.1) -1.6 (-2.4, -0.9) 0.48
7 -0.2 (-0.3, -0.1) -1.9 (-2.6, -1.2) 0.56
8 -0.2 (-0.3, -0.2) -2.2 (-2.9, -1.5) 0.64
9 -0.3 (-0.3, -0.2) -2.5 (-3.2, -1.8) 0.72
10 -0.3 (-0.4, -0.2) -2.7 (-3.5, -2.0) 0.80
11 -0.3 (-0.4, -0.2) -3.0 (-3.8, -2.2) 0.88
12 -0.3 (-0.4, -0.2) -3.3 (-4.2, -2.4) 0.96
13 -0.4 (-0.5, -0.3) -3.6 (-4.5, -2.6) 1.04
14 -0.4 (-0.5, -0.3) -3.8 (-4.9, -2.8) 1.12
15 -0.4 (-0.5, -0.3) -4.1 (-5.3, -2.9) 1.20
16 -0.5 (-0.6, -0.3) -4.4 (-5.7, -3.1) 1.27
1 0.0 (-0.3, 0.2) -0.2 (-1.2, 0.9) 0.07
2 -0.1 (-0.3, 0.1) -0.3 (-1.3, 0.6) 0.14
3 -0.1 (-0.3, 0.1) -0.5 (-1.4, 0.4) 0.21
4 -0.1 (-0.3, 0.0) -0.7 (-1.5, 0.1) 0.28
5 -0.2 (-0.3, 0.0) -0.8 (-1.6, -0.1) 0.35
6 -0.2 (-0.3, -0.1) -1.0 (-1.7, -0.3) 0.42
7 -0.2 (-0.4, -0.1) -1.2 (-1.8, -0.5) 0.49
8 -0.3 (-0.4, -0.1) -1.3 (-1.9, -0.7) 0.56
9 -0.3 (-0.4, -0.2) -1.5 (-2.1, -0.9) 0.63
10 -0.3 (-0.5, -0.2) -1.6 (-2.3, -1.0) 0.70
11 -0.4 (-0.5, -0.2) -1.8 (-2.5, -1.1) 0.77
12 -0.4 (-0.6, -0.3) -2.0 (-2.7, -1.2) 0.84
13 -0.5 (-0.6, -0.3) -2.1 (-3.0, -1.3) 0.91
14 -0.5 (-0.7, -0.3) -2.3 (-3.2, -1.4) 0.98
15 -0.5 (-0.7, -0.3) -2.5 (-3.5, -1.4) 1.05
16 -0.6 (-0.8, -0.3) -2.6 (-3.8, -1.5) 1.12
a

ARCHITECT IRIS V1
Shift and % Shift
Urine Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.1, 0.1) -0.3 (-1.3, 0.7) 0.07
2 -0.1 (-0.2, 0.0) -0.6 (-1.5, 0.3) 0.13
3 -0.1 (-0.2, 0.0) -0.9 (-1.7, -0.1) 0.20
4 -0.1 (-0.2, 0.0) -1.2 (-1.9, -0.4) 0.26
5 -0.2 (-0.2, -0.1) -1.5 (-2.2, -0.8) 0.33
6 -0.2 (-0.2, -0.1) -1.8 (-2.4, -1.2) 0.39
7 -0.2 (-0.3, -0.2) -2.1 (-2.7, -1.5) 0.46
8 -0.2 (-0.3, -0.2) -2.4 (-3.0, -1.8) 0.52
9 -0.3 (-0.3, -0.2) -2.7 (-3.3, -2.1) 0.59
10 -0.3 (-0.4, -0.2) -3.0 (-3.6, -2.4) 0.65
11 -0.3 (-0.4, -0.3) -3.3 (-3.9, -2.6) 0.72
12 -0.4 (-0.4, -0.3) -3.6 (-4.3, -2.9) 0.78
13 -0.4 (-0.5, -0.3) -3.9 (-4.7, -3.1) 0.85
14 -0.4 (-0.5, -0.3) -4.2 (-5.1, -3.3) 0.91
15 -0.5 (-0.6, -0.4) -4.5 (-5.4, -3.5) 0.98
16 -0.5 (-0.6, -0.4) -4.8 (-5.8, -3.7) 1.04
1 0.0 (-0.2, 0.2) -0.2 (-1.1, 0.8) 0.06
2 -0.1 (-0.3, 0.1) -0.4 (-1.2, 0.5) 0.12
3 -0.1 (-0.3, 0.1) -0.5 (-1.3, 0.3) 0.19
4 -0.1 (-0.3, 0.0) -0.7 (-1.4, 0.0) 0.25
5 -0.2 (-0.3, -0.1) -0.9 (-1.5, -0.2) 0.31
6 -0.2 (-0.3, -0.1) -1.1 (-1.7, -0.5) 0.37
7 -0.3 (-0.4, -0.1) -1.2 (-1.8, -0.7) 0.43
8 -0.3 (-0.4, -0.2) -1.4 (-2.0, -0.9) 0.49
9 -0.3 (-0.5, -0.2) -1.6 (-2.1, -1.0) 0.56
10 -0.4 (-0.5, -0.3) -1.8 (-2.3, -1.2) 0.62
11 -0.4 (-0.5, -0.3) -1.9 (-2.6, -1.3) 0.68
12 -0.4 (-0.6, -0.3) -2.1 (-2.8, -1.4) 0.74
13 -0.5 (-0.6, -0.3) -2.3 (-3.1, -1.6) 0.80
14 -0.5 (-0.7, -0.3) -2.5 (-3.3, -1.7) 0.87
15 -0.6 (-0.8, -0.4) -2.7 (-3.6, -1.7) 0.93
16 -0.6 (-0.8, -0.4) -2.8 (-3.8, -1.8) 0.99
a

ARCHITECT IRIS V1
Shift and % Shift
Urine Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.2, 0.1) -0.4 (-1.5, 0.8) 0.07
2 -0.1 (-0.2, 0.0) -0.7 (-1.8, 0.3) 0.15
3 -0.1 (-0.2, 0.0) -1.1 (-2.0, -0.2) 0.22
4 -0.2 (-0.2, -0.1) -1.5 (-2.3, -0.6) 0.29
5 -0.2 (-0.3, -0.1) -1.8 (-2.6, -1.1) 0.37
6 -0.2 (-0.3, -0.2) -2.2 (-2.9, -1.5) 0.44
7 -0.3 (-0.3, -0.2) -2.6 (-3.2, -1.9) 0.52
8 -0.3 (-0.4, -0.2) -3.0 (-3.6, -2.3) 0.59
9 -0.3 (-0.4, -0.3) -3.3 (-4.0, -2.7) 0.66
10 -0.4 (-0.5, -0.3) -3.7 (-4.4, -3.0) 0.74
11 -0.4 (-0.5, -0.3) -4.1 (-4.8, -3.3) 0.81
12 -0.5 (-0.5, -0.4) -4.4 (-5.2, -3.6) 0.88
13 -0.5 (-0.6, -0.4) -4.8 (-5.7, -3.9) 0.96
14 -0.5 (-0.6, -0.4) -5.2 (-6.2, -4.2) 1.03
15 -0.6 (-0.7, -0.5) -5.5 (-6.6, -4.4) 1.11
16 -0.6 (-0.7, -0.5) -5.9 (-7.1, -4.7) 1.18
1 0.0 (-0.3, 0.2) -0.2 (-1.2, 0.8) 0.06
2 -0.1 (-0.3, 0.1) -0.4 (-1.4, 0.5) 0.13
3 -0.1 (-0.3, 0.0) -0.7 (-1.5, 0.1) 0.19
4 -0.2 (-0.3, 0.0) -0.9 (-1.6, -0.2) 0.26
5 -0.2 (-0.4, -0.1) -1.1 (-1.8, -0.5) 0.32
6 -0.3 (-0.4, -0.2) -1.3 (-2.0, -0.7) 0.39
7 -0.3 (-0.5, -0.2) -1.6 (-2.2, -1.0) 0.45
8 -0.4 (-0.5, -0.3) -1.8 (-2.4, -1.2) 0.52
9 -0.4 (-0.5, -0.3) -2.0 (-2.6, -1.5) 0.58
10 -0.5 (-0.6, -0.3) -2.2 (-2.9, -1.6) 0.65
11 -0.5 (-0.7, -0.4) -2.5 (-3.1, -1.8) 0.71
12 -0.6 (-0.7, -0.4) -2.7 (-3.4, -2.0) 0.78
13 -0.6 (-0.8, -0.5) -2.9 (-3.7, -2.1) 0.84
14 -0.7 (-0.8, -0.5) -3.1 (-4.0, -2.3) 0.91
15 -0.7 (-0.9, -0.5) -3.4 (-4.3, -2.4) 0.97
16 -0.8 (-1.0, -0.5) -3.6 (-4.6, -2.5) 1.04
a

ARCHITECT IRIS V1
Table III.A.22
Shift and % Shift
Urine Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.2, 0.1) -0 (-2, 2) 0.1
2 0.0 (-0.2, 0.1) -0 (-2, 1) 0.2
3 -0.1 (-0.2, 0.1) -1 (-2, 1) 0.4
4 -0.1 (-0.2, 0.1) -1 (-2, 1) 0.5
5 -0.1 (-0.2, 0.0) -1 (-2, 0) 0.6
6 -0.1 (-0.2, 0.0) -1 (-2, 0) 0.7
7 -0.1 (-0.2, 0.0) -1 (-2, 0) 0.8
8 -0.1 (-0.2, 0.0) -2 (-3, 0) 1.0
9 -0.2 (-0.3, -0.1) -2 (-3, -1) 1.1
10 -0.2 (-0.3, -0.1) -2 (-3, -1) 1.2
11 -0.2 (-0.3, -0.1) -2 (-3, -1) 1.3
12 -0.2 (-0.3, -0.1) -2 (-4, -1) 1.4
13 -0.2 (-0.4, -0.1) -2 (-4, -1) 1.6
14 -0.2 (-0.4, -0.1) -3 (-4, -1) 1.7
15 -0.3 (-0.4, -0.1) -3 (-5, -1) 1.8
16 -0.3 (-0.5, -0.1) -3 (-5, -1) 1.9
1 0.0 (-0.4, 0.4) -0 (-3, 2) 0.2
2 -0.1 (-0.4, 0.3) -0 (-3, 2) 0.3
3 -0.1 (-0.4, 0.2) -1 (-3, 2) 0.5
4 -0.1 (-0.4, 0.2) -1 (-3, 1) 0.7
5 -0.1 (-0.4, 0.1) -1 (-3, 1) 0.8
6 -0.2 (-0.4, 0.1) -1 (-3, 0) 1.0
7 -0.2 (-0.4, 0.0) -1 (-3, 0) 1.1
8 -0.2 (-0.5, 0.0) -1 (-3, 0) 1.3
9 -0.3 (-0.5, 0.0) -2 (-3, 0) 1.5
10 -0.3 (-0.5, 0.0) -2 (-3, 0) 1.6
11 -0.3 (-0.6, -0.1) -2 (-4, 0) 1.8
12 -0.3 (-0.6, -0.1) -2 (-4, 0) 2.0
13 -0.4 (-0.7, -0.1) -2 (-4, 0) 2.1
14 -0.4 (-0.8, 0.0) -2 (-5, 0) 2.3
15 -0.4 (-0.8, 0.0) -3 (-5, 0) 2.4
16 -0.5 (-0.9, 0.0) -3 (-6, 0) 2.6
a

ARCHITECT IRIS V1
Shift and % Shift
Urine Samples
Shift % Shifta
Baseline Value
Mean (mg/dL) (%)
1 0.0 (-0.2, 0.1) -0 (-2, 1) 0.1
2 -0.1 (-0.2, 0.1) -1 (-3, 1) 0.2
3 -0.1 (-0.3, 0.0) -1 (-3, 0) 0.4
4 -0.2 (-0.3, 0.0) -2 (-3, 0) 0.5
5 -0.2 (-0.3, -0.1) -2 (-4, -1) 0.6
6 -0.2 (-0.4, -0.1) -3 (-4, -2) 0.7
7 -0.3 (-0.4, -0.2) -3 (-4, -2) 0.9
8 -0.3 (-0.4, -0.2) -4 (-5, -3) 1.0
9 -0.4 (-0.5, -0.3) -4 (-5, -3) 1.1
10 -0.4 (-0.5, -0.3) -5 (-6, -3) 1.2
11 -0.5 (-0.6, -0.3) -5 (-6, -4) 1.4
12 -0.5 (-0.6, -0.4) -5 (-7, -4) 1.5
13 -0.5 (-0.7, -0.4) -6 (-7, -4) 1.6
14 -0.6 (-0.7, -0.4) -6 (-8, -5) 1.7
15 -0.6 (-0.8, -0.5) -7 (-9, -5) 1.9
16 -0.7 (-0.8, -0.5) -7 (-9, -5) 2.0
1 -0.1 (-0.4, 0.3) -0 (-3, 2) 0.1
2 -0.2 (-0.5, 0.2) -1 (-3, 1) 0.3
3 -0.2 (-0.5, 0.1) -1 (-3, 0) 0.4
4 -0.3 (-0.6, 0.0) -2 (-4, 0) 0.6
5 -0.4 (-0.6, -0.1) -2 (-4, -1) 0.7
6 -0.5 (-0.7, -0.2) -3 (-4, -1) 0.9
7 -0.5 (-0.8, -0.3) -3 (-5, -2) 1.0
8 -0.6 (-0.8, -0.4) -4 (-5, -3) 1.2
9 -0.7 (-0.9, -0.5) -4 (-6, -3) 1.3
10 -0.8 (-1.0, -0.6) -5 (-6, -3) 1.5
11 -0.9 (-1.1, -0.6) -5 (-7, -4) 1.6
12 -0.9 (-1.2, -0.7) -6 (-7, -4) 1.8
13 -1.0 (-1.3, -0.7) -6 (-8, -4) 1.9
14 -1.1 (-1.4, -0.8) -7 (-9, -5) 2.1
15 -1.2 (-1.5, -0.8) -7 (-9, -5) 2.2
16 -1.2 (-1.6, -0.9) -8 (-10, -5) 2.4
a

ARCHITECT IRIS V1
Table III.A.23
Shift and % Shift
Serum Samples
Shift % Shifta
One-Sided One-Sided
Baseline Value
Slope 95% CL Value 95% CL
Sample Mean Slope Month (mg/dL SE
SE (Lower, (%) (Lower,
(mg/dL) )
Upper) Upper)
1 0.0 (-0.1, 0.1) 0.1 (-2.4, 2.5) 0.13
2 0.0 (-0.1, 0.1) 0.2 (-2.1, 2.4) 0.27
3 0.0 (-0.1, 0.1) 0.2 (-1.8, 2.3) 0.40
4 0.0 (-0.1, 0.1) 0.3 (-1.5, 2.2) 0.54
5 0.0 (-0.1, 0.1) 0.4 (-1.3, 2.1) 0.67
6 0.0 (-0.1, 0.1) 0.5 (-1.1, 2.1) 0.81
7 0.0 (0.0, 0.1) 0.6 (-1.0, 2.1) 0.94
Lyphochek Unassayed CC
4.8 0.0039 0.00648 8 0.0 (0.0, 0.1) 0.6 (-0.9, 2.2) 1.08
lvl 1
9 0.0 (0.0, 0.1) 0.7 (-0.8, 2.3) 1.21
10 0.0 (0.0, 0.1) 0.8 (-0.8, 2.4) 1.35
11 0.0 (0.0, 0.1) 0.9 (-0.9, 2.7) 1.48
12 0.0 (0.0, 0.1) 1.0 (-1.0, 2.9) 1.61
13 0.1 (-0.1, 0.2) 1.0 (-1.1, 3.2) 1.75
14 0.1 (-0.1, 0.2) 1.1 (-1.2, 3.5) 1.88
15 0.1 (-0.1, 0.2) 1.2 (-1.4, 3.8) 2.02
1 0.0 (-0.1, 0.2) 0.0 (-1.4, 1.5) 0.08
2 0.0 (-0.1, 0.1) 0.1 (-1.3, 1.4) 0.16
3 0.0 (-0.1, 0.1) 0.1 (-1.1, 1.3) 0.24
4 0.0 (-0.1, 0.1) 0.1 (-1.0, 1.2) 0.32
5 0.0 (-0.1, 0.1) 0.1 (-0.9, 1.2) 0.41
6 0.0 (-0.1, 0.1) 0.2 (-0.8, 1.1) 0.49
7 0.0 (-0.1, 0.1) 0.2 (-0.7, 1.1) 0.57
10.3 0.0027 0.00837 8 0.0 (-0.1, 0.1) 0.2 (-0.7, 1.1) 0.65
lvl 2
9 0.0 (-0.1, 0.1) 0.2 (-0.7, 1.2) 0.73
10 0.0 (-0.1, 0.1) 0.3 (-0.7, 1.3) 0.81
11 0.0 (-0.1, 0.1) 0.3 (-0.8, 1.4) 0.89
12 0.0 (-0.1, 0.2) 0.3 (-0.9, 1.5) 0.97
13 0.0 (-0.1, 0.2) 0.3 (-0.9, 1.6) 1.06
14 0.0 (-0.1, 0.2) 0.4 (-1.0, 1.8) 1.14
15 0.0 (-0.1, 0.2) 0.4 (-1.2, 2.0) 1.22
a

ARCHITECT IRIS V1
Table III.A.24
Shift and % Shift
Urine Samples
Shift % Shifta
One-Sided One-Sided
Baseline Value
(mg/dL) )
Upper) Upper)
1 0.0 (-0.4, 0.3) -0.3 (-3.7, 3.1) 0.19
2 -0.1 (-0.4, 0.3) -0.5 (-3.6, 2.5) 0.37
3 -0.1 (-0.4, 0.2) -0.8 (-3.6, 2.0) 0.56
4 -0.1 (-0.4, 0.1) -1.1 (-3.6, 1.4) 0.74
5 -0.1 (-0.4, 0.1) -1.4 (-3.7, 1.0) 0.93
6 -0.2 (-0.4, 0.1) -1.6 (-3.8, 0.5) 1.12
7 -0.2 (-0.4, 0.0) -1.9 (-4.0, 0.2) 1.30
Liquichek Urine CC
10.4 -0.0284 0.01926 8 -0.2 (-0.4, 0.0) -2.2 (-4.3, -0.1) 1.49
ctrl lvl 1
9 -0.3 (-0.5, 0.0) -2.5 (-4.6, -0.3) 1.67
10 -0.3 (-0.5, 0.0) -2.7 (-5.0, -0.5) 1.86
11 -0.3 (-0.6, -0.1) -3.0 (-5.5, -0.6) 2.05
12 -0.3 (-0.6, -0.1) -3.3 (-6.0, -0.6) 2.23
13 -0.4 (-0.7, -0.1) -3.6 (-6.5, -0.6) 2.42
14 -0.4 (-0.7, -0.1) -3.8 (-7.1, -0.6) 2.60
15 -0.4 (-0.8, -0.1) -4.1 (-7.7, -0.6) 2.79
1 0.0 (-0.6, 0.6) -0.1 (-3.1, 2.9) 0.17
2 0.0 (-0.6, 0.5) -0.1 (-2.9, 2.6) 0.33
3 0.0 (-0.6, 0.5) -0.2 (-2.7, 2.3) 0.50
4 -0.1 (-0.5, 0.4) -0.3 (-2.5, 2.0) 0.66
5 -0.1 (-0.5, 0.4) -0.3 (-2.4, 1.7) 0.83
6 -0.1 (-0.5, 0.3) -0.4 (-2.4, 1.5) 0.99
7 -0.1 (-0.5, 0.3) -0.5 (-2.3, 1.4) 1.16
Liquichek Urine CC
21.0 -0.0145 0.03476 8 -0.1 (-0.5, 0.3) -0.6 (-2.4, 1.3) 1.32
ctrl lvl 2
9 -0.1 (-0.5, 0.3) -0.6 (-2.5, 1.3) 1.49
10 -0.1 (-0.6, 0.3) -0.7 (-2.7, 1.3) 1.66
11 -0.2 (-0.6, 0.3) -0.8 (-2.9, 1.4) 1.82
12 -0.2 (-0.7, 0.3) -0.8 (-3.2, 1.6) 1.99
13 -0.2 (-0.7, 0.4) -0.9 (-3.5, 1.7) 2.15
14 -0.2 (-0.8, 0.4) -1.0 (-3.9, 1.9) 2.32
15 -0.2 (-0.9, 0.4) -1.0 (-4.2, 2.1) 2.48
a

ARCHITECT IRIS V1
Table III.A.25
Condition: Inverted (INV)
Shift and % Shift
Serum Samples
Shift % Shifta
One-Sided One-Sided
Baseline Value
(mg/dL) )
Upper) Upper)
1 0.0 (0.0, 0.0) -0 (-1, 1) 0.1
2 0.0 (0.0, 0.0) -0 (-1, 1) 0.1
3 0.0 (0.0, 0.0) -0 (-1, 1) 0.2
4 0.0 (0.0, 0.0) -0 (-1, 1) 0.2
5 0.0 (0.0, 0.0) -0 (-1, 1) 0.3
6 0.0 (0.0, 0.0) -0 (-1, 0) 0.3
7 0.0 (0.0, 0.0) -0 (-1, 0) 0.4
4.8 -0.0009 0.00250 8 0.0 (0.0, 0.0) -0 (-1, 0) 0.4
lvl 1
9 0.0 (0.0, 0.0) -0 (-1, 0) 0.5
10 0.0 (0.0, 0.0) -0 (-1, 0) 0.5
11 0.0 (0.0, 0.0) -0 (-1, 0) 0.6
12 0.0 (0.0, 0.0) -0 (-1, 1) 0.6
13 0.0 (-0.1, 0.0) -0 (-1, 1) 0.7
14 0.0 (-0.1, 0.0) -0 (-1, 1) 0.7
15 0.0 (-0.1, 0.0) -0 (-1, 1) 0.8
1 0.0 (-0.2, 0.2) 0 (-2, 2) 0.1
2 0.0 (-0.2, 0.2) 0 (-2, 2) 0.2
3 0.0 (-0.1, 0.2) 0 (-1, 2) 0.3
4 0.0 (-0.1, 0.2) 0 (-1, 1) 0.4
5 0.0 (-0.1, 0.1) 0 (-1, 1) 0.5
6 0.0 (-0.1, 0.1) 0 (-1, 1) 0.6
7 0.0 (-0.1, 0.1) 0 (-1, 1) 0.7
10.3 0.0042 0.00985 8 0.0 (-0.1, 0.1) 0 (-1, 1) 0.8
lvl 2
9 0.0 (-0.1, 0.2) 0 (-1, 1) 0.9
10 0.0 (-0.1, 0.2) 0 (-1, 2) 1.0
11 0.0 (-0.1, 0.2) 0 (-1, 2) 1.1
12 0.1 (-0.1, 0.2) 0 (-1, 2) 1.2
13 0.1 (-0.1, 0.2) 1 (-1, 2) 1.2
14 0.1 (-0.1, 0.2) 1 (-1, 2) 1.3
15 0.1 (-0.1, 0.3) 1 (-1, 2) 1.4
a

ARCHITECT IRIS V1
Table III.A.26
Condition: Inverted (INV)
Shift and % Shift
Urine Samples
Shift % Shifta
One-Sided One-Sided
Baseline Value
(mg/dL) )
Upper) Upper)
1 -0.1 (-0.2, 0.1) -0 (-2, 1) 0.1
2 -0.1 (-0.3, 0.1) -1 (-2, 1) 0.2
3 -0.2 (-0.3, 0.0) -1 (-3, 0) 0.3
4 -0.2 (-0.3, -0.1) -2 (-3, -1) 0.4
5 -0.3 (-0.4, -0.1) -2 (-4, -1) 0.5
6 -0.3 (-0.4, -0.2) -3 (-4, -2) 0.5
7 -0.4 (-0.5, -0.2) -3 (-4, -2) 0.6
Liquichek Urine
10.3 -0.0501 0.00936 8 -0.4 (-0.5, -0.3) -4 (-5, -3) 0.7
CC ctrl lvl 1
9 -0.5 (-0.6, -0.3) -4 (-5, -3) 0.8
10 -0.5 (-0.6, -0.4) -5 (-6, -4) 0.9
11 -0.6 (-0.7, -0.4) -5 (-7, -4) 1.0
12 -0.6 (-0.7, -0.5) -6 (-7, -5) 1.1
13 -0.7 (-0.8, -0.5) -6 (-8, -5) 1.2
14 -0.7 (-0.9, -0.5) -7 (-8, -5) 1.3
15 -0.8 (-0.9, -0.6) -7 (-9, -6) 1.4
1 -0.1 (-0.3, 0.2) -0 (-2, 1) 0.1
2 -0.1 (-0.4, 0.1) -1 (-2, 0) 0.1
3 -0.2 (-0.4, 0.0) -1 (-2, 0) 0.2
4 -0.3 (-0.5, -0.1) -1 (-2, 0) 0.3
5 -0.3 (-0.5, -0.2) -2 (-2, -1) 0.3
6 -0.4 (-0.6, -0.2) -2 (-3, -1) 0.4
7 -0.5 (-0.6, -0.3) -2 (-3, -1) 0.5
Liquichek Urine
21.1 -0.0657 0.01388 8 -0.5 (-0.7, -0.4) -2 (-3, -2) 0.5
CC ctrl lvl 2
9 -0.6 (-0.8, -0.4) -3 (-4, -2) 0.6
10 -0.7 (-0.8, -0.5) -3 (-4, -2) 0.7
11 -0.7 (-0.9, -0.5) -3 (-4, -3) 0.7
12 -0.8 (-1.0, -0.6) -4 (-5, -3) 0.8
13 -0.9 (-1.1, -0.6) -4 (-5, -3) 0.9
14 -0.9 (-1.2, -0.7) -4 (-6, -3) 0.9
15 -1.0 (-1.3, -0.7) -5 (-6, -3) 1.0
a

ARCHITECT IRIS V1
Table.III.A.27
On-Test Material: Reagent Lot 1, 2, 3 (4 x 500) and 4 (4 x160)
Shift and % Shift
Serum Samples
Shifta % Shiftb
Test Valu
Sub Baseline Two-
Test Point e Two-Sided Value
Lot Sample Test Mean Sided
Point Mean (mg/ 95% CL (%)
Point (mg/dL) 95% CL
(mg/dL) dL)
Month Day
4.7 4.7 0.0 (0.0, 0.0) 0 (0, 0)
02 OBS 15
Month Day
4.7 4.8 0.1 (0.0, 0.1) 1 (0, 2)
02 OBS 31
Month Day
Lyphochek 4.7 4.7 -0.0 (-0.1, 0.0) -1 (-2, 0)
08 OBS 15
Unassayed
Month Day
CC lvl 1 4.7 4.7 0.0 (-0.1, 0.1) 0 (-1, 1)
08 OBS 31
Month Day
4.7 4.7 -0.1 (-0.1, 0.0) -1 (-2, 0)
15 OBS 15
Month Day
4.7 4.7 -0.0 (-0.1, 0.0) -1 (-2, 0)
Reagent Lot 1 15 OBS 31
UACI10012 Month Day
10.2 10.0 -0.2 (-0.3, -0.1) -2 (-3, -1)
02 OBS 15
Month Day
10.2 10.4 0.2 (0.1, 0.2) 2 (1, 2)
02 OBS 31
Month Day
Lyphochek 10.3 10.2 -0.1 (-0.1, -0.1) -1 (-1, -1)
08 OBS 15
Unassayed
Month Day
CC lvl 2 10.3 10.2 -0.1 (-0.1, -0.1) -1 (-1, -1)
08 OBS 31
Month Day
10.3 10.3 -0.0 (-0.1, 0.0) -0 (-1, 0)
15 OBS 15
Month Day
10.3 10.3 0.0 (0.0, 0.0) 0 (0, 0)
15 OBS 31
Month Day
4.7 4.7 0.0 (0.0, 0.0) 0 (0, 1)
02 OBS 15
Month Day
4.7 4.7 0.0 (0.0, 0.0) 0 (0, 0)
02 OBS 31
Month Day
Lyphochek 4.8 4.7 -0.0 (-0.1, 0.0) -1 (-2, 0)
08 OBS 15
Unassayed
Month Day
CC lvl 1 4.8 4.7 -0.0 (-0.1, 0.0) -1 (-2, 1)
08 OBS 31
Month Day
4.7 4.7 -0.0 (-0.1, 0.0) -1 (-1, 0)
15 OBS 15
Month Day
4.7 4.7 -0.0 (-0.1, 0.0) -1 (-1, 0)
UACI10026 Month Day
10.2 10.0 -0.2 (-0.2, -0.2) -2 (-2, -2)
02 OBS 15
Month Day
10.2 10.3 0.1 (0.1, 0.1) 1 (1, 1)
02 OBS 31
Month Day
Lyphochek 10.2 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
08 OBS 15
Unassayed
Month Day
CC lvl 2 10.2 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
08 OBS 31
Month Day
10.3 10.2 -0.1 (-0.1, 0.0) -1 (-1, 0)
15 OBS 15
Month Day
10.3 10.3 0.0 (0.0, 0.0) 0 (0, 0)
15 OBS 31

ARCHITECT IRIS V1
Table.III.A.27 (Continued)
On-Test Material: Reagent Lot 1, 2, 3 (4 x 500) and 4 (4 x 160)
Shift and % Shift
Serum Samples
Shifta % Shiftb
Test
Sub Baseline Value Two- Two-
Test Point Value
Lot Sample Test Mean (mg/d Sided Sided
Point Mean (%)
Point (mg/dL) L) 95% CL 95% CL
(mg/dL)
Month Day
4.7 4.7 0.0 (0.0, 0.0) 0 (0, 1)
02 OBS 15
Month Day
4.7 4.7 0.0 (0.0, 0.0) 0 (0, 1)
02 OBS 31
Month Day (-0.1, -
Lyphochek 4.8 4.7 -0.1 -2 (-2, -1)
08 OBS 15 0.1)
Unassayed
Month Day
CC lvl 1 4.8 4.8 -0.0 (-0.1, 0.0) -1 (-2, 1)
08 OBS 31
Month Day
4.7 4.7 -0.0 (0.0, 0.0) -0 (-1, 0)
15 OBS 15
Month Day
4.7 4.7 -0.0 (0.0, 0.0) -0 (-1, 0)
UACI10040 Month Day (-0.2, -
10.2 10.0 -0.2 -2 (-2, -1)
02 OBS 15 0.1)
Month Day
10.2 10.3 0.1 (0.1, 0.1) 1 (1, 1)
02 OBS 31
Month Day
Lyphochek 10.2 10.1 -0.1 (-0.1, 0.0) -1 (-1, 0)
08 OBS 15
Unassayed
Month Day (-0.1, -
CC lvl 2 10.2 10.1 -0.1 -1 (-1, -1)
08 OBS 31 0.1)
Month Day
10.3 10.3 -0.0 (-0.1, 0.1) -0 (-1, 1)
15 OBS 15
Month Day
10.3 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
15 OBS 31
Month Day
4.7 4.7 0.0 (0.0, 0.0) 0 (0, 1)
02 OBS 15
Month Day
4.7 4.8 0.1 (0.1, 0.2) 3 (2, 5)
02 OBS 31
Month Day
Lyphochek 4.7 4.7 0.0 (0.0, 0.0) 0 (0, 1)
08 OBS 15
Unassayed
Month Day
CC lvl 1 4.7 4.7 0.0 (0.0, 0.0) 0 (0, 0)
08 OBS 31
Month Day
4.7 4.7 -0.0 (-0.1, 0.0) -1 (-2, 0)
15 OBS 15
Month Day
4.7 4.7 -0.0 (-0.1, 0.0) -1 (-2, 1)
UACI10039 Month Day (-0.2, -
10.2 10.0 -0.2 -2 (-2, -2)
02 OBS 15 0.2)
Month Day
10.2 10.6 0.4 (0.4, 0.4) 4 (3, 4)
02 OBS 31
Month Day
Lyphochek 10.2 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
08 OBS 15
Unassayed
Month Day
CC lvl 2 10.2 10.2 -0.1 (-0.1, 0.0) -1 (-1, 0)
08 OBS 31
Month Day
10.3 10.3 -0.1 (-0.1, 0.0) -1 (-1, 0)
15 OBS 15
Month Day
10.3 10.3 -0.0 (-0.1, 0.0) -0 (-1, 0)
15 OBS 31

ARCHITECT IRIS V1
Table.III.A.28
On-Test Material: Reagent Lot 5 (4 x 500)
Shift and % Shift
Serum Samples
Shifta % Shiftb
Test
Test Point Value
Point Mean (%)
(mg/dL)
Month Day (-0.1, -
4.8 4.7 -0.1 -3 (-3, -2)
02 OBS 15 0.1)
Month Day (-0.2, -
4.8 4.6 -0.2 -4 (-5, -4)
02 OBS 31 0.2)
Month Day
4.8 4.8 -0.0 (-0.1, 0.0) -1 (-1, 0)
06 OBS 15
Month Day (-0.1, -
4.8 4.7 -0.1 -2 (-2, -2)
06 OBS 31 0.1)
Month Day
Lyphochek 4.8 4.8 0.0 (0.0, 0.0) 0 (0, 0)
08 OBS 15
Unassayed
Month Day (-0.1, -
CC lvl 1 4.8 4.7 -0.1 -2 (-2, -2)
08 OBS 31 0.1)
Month Day
4.8 4.9 0.0 (0.0, 0.1) 1 (0, 2)
12 OBS 15
Month Day
4.8 4.9 0.1 (0.1, 0.1) 2 (1, 2)
12 OBS 31
Month Day
4.8 4.8 -0.0 (0.0, 0.0) -0 (-1, 0)
15 OBS 15
Month Day (-0.1, -
4.8 4.7 -0.1 -2 (-2, -2)
Reagent Lot 5 15 OBS 31 0.1)
(93917UI00) Month Day (-0.2, -
9.9 9.7 -0.2 -2 (-2, -2)
02 OBS 15 0.2)
Month Day (-0.3, -
9.9 9.6 -0.3 -3 (-3, -2)
02 OBS 31 0.2)
Month Day
9.8 9.8 -0.1 (-0.1, 0.0) -1 (-1, 0)
06 OBS 15
Month Day (-0.2, -
9.8 9.7 -0.1 -1 (-2, -1)
06 OBS 31 0.1)
Month Day
Lyphochek 9.8 9.8 0.0 (0.0, 0.0) 0 (0, 0)
08 OBS 15
Unassayed
Month Day (-0.3, -
CC lvl 2 9.8 9.6 -0.2 -2 (-3, -2)
08 OBS 31 0.2)
Month Day
9.8 9.9 0.1 (0.0, 0.1) 1 (0, 1)
12 OBS 15
Month Day
9.8 9.9 0.1 (0.0, 0.1) 1 (0, 1)
12 OBS 31
Month Day
10.1 10.1 -0.0 (-0.1, 0.0) -0 (-1, 0)
15 OBS 15
Month Day (-0.2, -
10.1 10.0 -0.1 -1 (-2, -1)
15 OBS 31 0.1)

ARCHITECT IRIS V1
Shift and % Shift
Serum Samples
Shifta % Shiftb
Test
Test Point Value
Point Mean (%)
(mg/dL)
Month Day (-0.2, -
4.8 4.6 -0.2 -3 (-4, -3)
02 OBS 15 0.1)
Month Day (-0.2, -
4.8 4.6 -0.2 -4 (-4, -3)
02 OBS 31 0.2)
Month Day
4.8 4.8 -0.0 (0.0, 0.0) -0 (-1, 0)
06 OBS 15
Month Day
4.8 4.8 -0.0 (-0.1, 0.0) -1 (-2, 0)
06 OBS 31
Month Day
Lyphochek 4.8 4.8 0.0 (0.0, 0.0) 0 (0, 0)
08 OBS 15
Unassayed
Month Day (-0.1, -
CC lvl 1 4.8 4.7 -0.1 -2 (-3, -2)
08 OBS 31 0.1)
Month Day
4.8 4.8 0.0 (0.0, 0.1) 1 (0, 1)
12 OBS 15
Month Day
4.8 4.8 0.1 (0.0, 0.1) 1 (1, 2)
12 OBS 31
Month Day
4.7 4.6 -0.0 (-0.1, 0.0) -1 (-2, 0)
15 OBS 15
Month Day
4.7 4.6 -0.1 (-0.1, 0.0) -1 (-2, -1)
(93918UI00) Month Day (-0.2, -
9.8 9.6 -0.2 -2 (-2, -1)
02 OBS 15 0.1)
Month Day (-0.2, -
9.8 9.6 -0.2 -2 (-2, -2)
02 OBS 31 0.2)
Month Day (-0.1, -
9.9 9.8 -0.1 -1 (-1, -1)
06 OBS 15 0.1)
Month Day (-0.2, -
9.9 9.7 -0.1 -1 (-2, -1)
06 OBS 31 0.1)
Month Day
Lyphochek 9.9 9.8 -0.1 (-0.1, 0.0) -1 (-1, 0)
08 OBS 15
Unassayed
Month Day (-0.3, -
CC lvl 2 9.9 9.6 -0.3 -3 (-3, -3)
08 OBS 31 0.2)
Month Day
9.8 9.9 0.1 (0.0, 0.1) 1 (0, 1)
12 OBS 15
Month Day
9.8 9.9 0.1 (0.0, 0.1) 1 (0, 1)
12 OBS 31
Month Day
10.2 10.1 -0.1 (-0.1, 0.0) -0 (-1, 0)
15 OBS 15
Month Day (-0.2, -
10.2 10.0 -0.1 -1 (-1, -1)
15 OBS 31 0.1)

ARCHITECT IRIS V1
Table III.A.29
On-Test Material: Reagent Lots 1, 2, 3 (4 x 500) and 4 (4 x 160)
Shift and % Shift
Urine Samples
Shifta % Shiftb
Test
Sub Baseline Two- Two-
Test Point Value Value
Lot Sample Test Mean Sided Sided
Point Mean (mg/dL) (%)
Point (mg/dL) 95% CL 95% CL
(mg/dL)
Month Day
10.1 10.1 0.1 (0.0, 0.2) 1 (0, 2)
02 OBS 15
Month Day
10.1 10.4 0.3 (0.2, 0.4) 3 (2, 4)
02 OBS 31
Month Day
Liquichek 10.0 10.1 0.0 (-0.1, 0.2) 0 (-1, 2)
08 OBS 15
Urine CC
Month Day
lvl 1 10.0 10.1 0.1 (0.0, 0.2) 1 (0, 2)
08 OBS 31
Month Day
9.5 9.4 -0.1 (-0.2, 0.0) -1 (-2, 0)
15 OBS 15
Month Day
9.5 9.5 0.0 (-0.1, 0.1) 0 (-1, 2)
UACI10012 Month Day
20.8 20.8 0.0 (-0.2, 0.2) 0 (-1, 1)
02 OBS 15
Month Day
20.8 21.2 0.4 (0.3, 0.6) 2 (1, 3)
02 OBS 31
Month Day
Liquichek 20.7 20.5 -0.1 (-0.3, 0.0) -1 (-2, 0)
08 OBS 15
Urine CC
Month Day
lvl 2 20.7 20.8 0.2 (0.0, 0.3) 1 (0, 2)
08 OBS 31
Month Day
16.6 16.4 -0.2 (-0.3, 0.0) -1 (-2, 0)
15 OBS 15
Month Day
16.6 16.6 -0.0 (-0.1, 0.1) -0 (-1, 1)
15 OBS 31
Month Day
10.0 10.0 0.0 (-0.1, 0.1) 0 (-1, 1)
02 OBS 15
Month Day
10.0 10.2 0.2 (0.1, 0.3) 2 (1, 3)
02 OBS 31
Month Day
Liquichek 10.0 10.1 0.1 (0.0, 0.1) 1 (0, 1)
08 OBS 15
Urine CC
Month Day
lvl 1 10.0 10.2 0.2 (0.1, 0.3) 2 (1, 3)
08 OBS 31
Month Day
9.5 9.4 -0.1 (-0.3, 0.0) -2 (-3, 0)
15 OBS 15
Month Day
9.5 9.5 -0.0 (-0.1, 0.1) -0 (-1, 1)
UACI10026 Month Day
20.7 20.7 -0.0 (-0.3, 0.2) -0 (-1, 1)
02 OBS 15
Month Day
20.7 20.9 0.1 (0.0, 0.3) 1 (0, 1)
02 OBS 31
Month Day
Liquichek 20.7 20.7 0.0 (-0.2, 0.2) 0 (-1, 1)
08 OBS 15
Urine CC
Month Day
lvl 2 20.7 20.9 0.2 (0.0, 0.4) 1 (0, 2)
08 OBS 31
Month Day
16.5 16.3 -0.2 (-0.4, 0.0) -1 (-2, 0)
15 OBS 15
Month Day
16.5 16.5 0.0 (-0.1, 0.1) 0 (-1, 1)
15 OBS 31

ARCHITECT IRIS V1
On-Test Material: Reagent Lots 1, 2, 3 (4 x 500) and 4 (4 x 160)
Shift and % Shift
Urine Samples
Shifta % Shiftb
Test
Sub Baseline Value Two-
Test Point Two-Sided Value
Lot Sample Test Mean (mg/d Sided
Point Mean 95% CL (%)
Point (mg/dL) L) 95% CL
(mg/dL)
Month Day
10.1 10.1 -0.0 (-0.2, 0.2) -0 (-2, 2)
02 OBS 15
Month Day
10.1 10.2 0.2 (0.0, 0.3) 2 (0, 3)
02 OBS 31
Month Day
Liquichek 10.1 10.1 -0.0 (-0.1, 0.1) -0 (-1, 1)
08 OBS 15
Urine CC
Month Day
lvl 1 10.1 10.1 -0.0 (-0.1, 0.1) -0 (-1, 1)
08 OBS 31
Month Day
9.4 9.4 -0.0 (-0.1, 0.1) -0 (-1, 1)
15 OBS 15
Month Day
9.4 9.5 0.1 (-0.1, 0.2) 1 (-1, 2)
UACI10040 Month Day
20.7 20.8 0.1 (0.0, 0.3) 1 (0, 2)
02 OBS 15
Month Day
20.7 21.0 0.3 (0.1, 0.4) 1 (1, 2)
02 OBS 31
Month Day
Liquichek 20.8 20.6 -0.1 (-0.3, 0.1) -1 (-1, 0)
08 OBS 15
Urine CC
Month Day
lvl 2 20.8 20.8 0.0 (-0.1, 0.2) 0 (-1, 1)
08 OBS 31
Month Day
16.4 16.4 -0.0 (-0.2, 0.2) -0 (-1, 1)
15 OBS 15
Month Day
16.4 16.6 0.2 (0.1, 0.3) 1 (0, 2)
15 OBS 31
Month Day
10.0 10.1 0.0 (-0.1, 0.2) 0 (-1, 2)
02 OBS 15
Month Day
10.0 10.4 0.4 (0.3, 0.5) 4 (3, 5)
02 OBS 31
Month Day
Liquichek 9.9 10.0 0.1 (0.0, 0.2) 1 (0, 2)
08 OBS 15
Urine CC
Month Day
lvl 1 9.9 10.1 0.1 (0.0, 0.3) 1 (0, 3)
08 OBS 31
Month Day
9.5 9.4 -0.1 (-0.2, 0.1) -1 (-2, 1)
15 OBS 15
Month Day
9.5 9.6 0.1 (0.0, 0.2) 1 (0, 2)
UACI10039 Month Day
20.7 20.7 -0.0 (-0.2, 0.2) -0 (-1, 1)
02 OBS 15
Month Day
20.7 21.4 0.7 (0.5, 0.8) 3 (2, 4)
02 OBS 31
Month Day
Liquichek 20.7 20.5 -0.1 (-0.3, 0.0) -1 (-1, 0)
08 OBS 15
Urine CC
Month Day
lvl 2 20.7 20.7 0.1 (-0.1, 0.2) 0 (0, 1)
08 OBS 31
Month Day
16.5 16.5 -0.0 (-0.2, 0.1) -0 (-1, 1)
15 OBS 15
Month Day
16.5 16.7 0.2 (0.0, 0.3) 1 (0, 2)
15 OBS 31

ARCHITECT IRIS V1
Table.III.A.30
Shift and % Shift
Urine Samples
Shifta % Shiftb
Test
Test Point Value
Point Mean (%)
(mg/dL)
Month Day (-0.3, -
9.1 8.9 -0.2 -2 (-3, -2)
02 OBS 15 0.1)
Month Day (-0.4, -
9.1 8.8 -0.3 -3 (-4, -3)
02 OBS 31 0.2)
Month Day
8.9 9.0 0.1 (0.0, 0.1) 1 (0, 2)
06 OBS 15
Month Day
8.9 8.8 -0.0 (-0.1, 0.0) -0 (-1, 0)
06 OBS 31
Month Day
Liquichek 9.2 9.1 -0.1 (-0.1, 0.0) -1 (-2, 0)
08 OBS 15
Urine CC
Month Day (-0.4, -
ctrl lvl 1 9.2 8.9 -0.3 -3 (-4, -2)
08 OBS 31 0.2)
Month Day
9.2 9.2 0.0 (0.0, 0.1) 0 (0, 1)
12 OBS 15
Month Day
9.2 9.4 0.3 (0.2, 0.3) 3 (2, 4)
12 OBS 31
Month Day
9.3 9.2 -0.1 (-0.2, 0.0) -1 (-2, 0)
15 OBS 15
Month Day (-0.4, -
9.3 9.0 -0.3 -4 (-4, -3)
(93917UI00) Month Day (-0.4, -
16.2 15.9 -0.3 -2 (-2, -1)
02 OBS 15 0.2)
Month Day (-0.5, -
16.2 15.8 -0.4 -3 (-3, -2)
02 OBS 31 0.4)
Month Day
15.8 15.9 0.1 (0.0, 0.2) 1 (0, 1)
06 OBS 15
Month Day (-0.3, -
15.8 15.6 -0.2 -1 (-2, -1)
06 OBS 31 0.2)
Month Day
Liquichek 16.3 16.3 -0.0 (-0.1, 0.1) -0 (-1, 0)
08 OBS 15
Urine CC
Month Day (-0.4, -
ctrl lvl 2 16.3 16.0 -0.3 -2 (-2, -1)
08 OBS 31 0.2)
Month Day
23.1 23.3 0.3 (0.1, 0.4) 1 (0, 2)
12 OBS 15
Month Day
23.1 23.3 0.3 (0.1, 0.4) 1 (0, 2)
12 OBS 31
Month Day
23.1 23.0 -0.0 (-0.2, 0.1) -0 (-1, 0)
15 OBS 15
Month Day (-0.4, -
23.1 22.8 -0.3 -1 (-2, -1)
15 OBS 31 0.1)

ARCHITECT IRIS V1
Shift and % Shift
Urine Samples
Shifta % Shiftb
Test
Test Point Value
Point Mean (%)
(mg/dL)
Month Day (-0.4, -
9.0 8.6 -0.3 -4 (-4, -3)
02 OBS 15 0.3)
Month Day (-0.4, -
9.0 8.6 -0.3 -4 (-4, -3)
02 OBS 31 0.3)
Month Day
8.9 9.1 0.2 (0.1, 0.2) 2 (1, 3)
06 OBS 15
Month Day
8.9 8.9 0.0 (0.0, 0.1) 0 (0, 1)
06 OBS 31
Month Day
Liquichek 9.1 9.0 -0.1 (-0.1, 0.0) -1 (-1, 0)
08 OBS 15
Urine CC
Month Day (-0.3, -
ctrl lvl 1 9.1 8.9 -0.2 -2 (-3, -2)
08 OBS 31 0.1)
Month Day
9.0 9.1 0.1 (0.1, 0.2) 1 (1, 2)
12 OBS 15
Month Day
9.0 9.1 0.2 (0.1, 0.2) 2 (1, 3)
12 OBS 31
Month Day (-0.4, -
9.0 8.7 -0.3 -3 (-4, -3)
15 OBS 15 0.2)
Month Day (-0.4, -
9.0 8.7 -0.3 -4 (-4, -3)
(93918UI00) Month Day (-0.5, -
15.9 15.5 -0.4 -3 (-3, -2)
02 OBS 15 0.3)
Month Day (-0.6, -
15.9 15.4 -0.5 -3 (-4, -3)
02 OBS 31 0.4)
Month Day
15.8 15.9 0.1 (0.0, 0.2) 1 (0, 1)
06 OBS 15
Month Day
15.8 15.7 -0.1 (-0.2, 0.0) -1 (-2, 0)
06 OBS 31
Month Day
Liquichek 16.2 16.1 -0.1 (-0.2, 0.1) -0 (-1, 0)
08 OBS 15
Urine CC
Month Day (-0.4, -
ctrl lvl 2 16.2 15.9 -0.3 -2 (-2, -1)
08 OBS 31 0.2)
Month Day
22.6 22.8 0.1 (0.0, 0.2) 1 (0, 1)
12 OBS 15
Month Day
22.6 22.7 0.1 (0.0, 0.2) 0 (0, 1)
12 OBS 31
Month Day (-0.5, -
22.4 22.0 -0.3 -1 (-2, -1)
15 OBS 15 0.2)
Month Day (-0.3, -
22.4 22.1 -0.2 -1 (-1, -1)
15 OBS 31 0.1)

ARCHITECT IRIS V1
Table III.A.31
Shift and % Shift
Serum Samples
Shifta % Shiftb
Test
Baseline Value Two-
Test Point Value Two-Sided
Lot Sample Sub Test Point Mean (mg/dL Sided
Point Mean (%) 95% CL
(mg/dL) ) 95% CL
(mg/dL)
Month 03 Transport Stress 1 4.8 4.8 -0.1 (-0.1, 0.0) -1 (-2, 0)
Month 06 Transport Stress 1 4.8 4.8 0.0 (0.0, 0.0) 0 (0, 1)
Lyphochek Month 09 Transport Stress 1 4.8 4.7 -0.1 (-0.1, -0.1) -2 (-2, -2)
Unassayed Month 12 Transport Stress 1 4.7 4.7 -0.0 (-0.1, 0.0) -0 (-2, 1)
CC lvl 1 Month 12 Transport Stress 2 4.7 4.7 -0.0 (-0.1, 0.0) -0 (-2, 1)
Month 15 Transport Stress 1 4.7 4.7 0.0 (0.0, 0.0) 0 (0, 0)
Reagent Lot 4 Month 15 Transport Stress 3 4.7 4.7 0.0 (0.0, 0.1) 1 (0, 1)
(UACI10039) Month 03 Transport Stress 1 10.4 10.3 -0.1 (-0.1, 0.0) -1 (-1, 0)
Month 06 Transport Stress 1 10.2 10.2 0.0 (-0.1, 0.1) 0 (-1, 1)
Lyphochek Month 09 Transport Stress 1 10.4 10.3 -0.1 (-0.1, 0.0) -1 (-1, 0)
Unassayed Month 12 Transport Stress 1 10.3 10.3 0.0 (-0.1, 0.1) 0 (-1, 1)
CC lvl 2 Month 12 Transport Stress 2 10.3 10.3 0.0 (-0.1, 0.1) 0 (-1, 1)
Month 15 Transport Stress 1 10.3 10.2 -0.1 (-0.1, -0.1) -1 (-1, -1)
a
Shift = Test Point Mean - Baseline Mean.
a,b

ARCHITECT IRIS V1
Table III.A.32
Shift and % Shift
Urine Samples
Shifta % Shiftb
Test
Baseline Value Two-
Test Point Value Two-Sided
Lot Sample Sub Test Point Mean (mg/dL Sided
Point Mean (%) 95% CL
(mg/dL) ) 95% CL
(mg/dL)
Month 03 Transport Stress 1 10.4 10.1 -0.3 (-0.4, -0.2) -3 (-4, -2)
Liquichek Month 09 Transport Stress 1 10.1 9.8 -0.3 (-0.5, -0.1) -3 (-5, -1)
Urine CC Month 12 Transport Stress 1 9.8 9.7 -0.0 (-0.3, 0.2) -0 (-3, 2)
ctrl lvl 1 Month 12 Transport Stress 2 9.8 9.6 -0.2 (-0.4, 0.1) -2 (-4, 1)
Reagent Lot 4 Month 15 Transport Stress 3 9.5 9.4 -0.1 (-0.2, 0.0) -1 (-2, 0)
(UACI10039) Month 03 Transport Stress 1 21.2 20.6 -0.6 (-0.8, -0.4) -3 (-4, -2)
Month 06 Transport Stress 1 21.0 21.0 0.1 (-0.2, 0.3) 0 (-1, 1)
Liquichek Month 09 Transport Stress 1 21.0 20.4 -0.5 (-1.0, -0.1) -3 (-5, 0)
Urine CC Month 12 Transport Stress 1 20.7 20.6 -0.1 (-0.4, 0.2) -0 (-2, 1)
ctrl lvl 2 Month 12 Transport Stress 2 20.7 20.3 -0.4 (-0.8, 0.0) -2 (-4, 0)
Month 15 Transport Stress 3 16.4 16.5 0.0 (-0.1, 0.1) 0 (0, 1)
a
a,b

ARCHITECT IRIS V1
Table.III.A.33
(Transport + OBS)
Shift and % Shift
Serum Samples
Shifta % Shiftb
Test
Baseline Two- Two-
Sample Sub Test Point Mean Sided Sided
(mg/dL) 95% CL 95% CL
(mg/dL)
Day 0 Transport (-0.1, -
Month 12 4.8 4.7 -0.1 -2 (-2, -1)
OBS Stress 1 0.1)
Month 12 4.8 4.7 -0.1 -2 (-2, -1)
OBS Stress 2 0.1)
Day 15 Transport
Month 12 4.8 4.7 -0.1 (-0.1, 0.0) -1 (-2, -1)
OBS Stress 1
Day 15 Transport
Month 12 4.8 4.8 0.0 (0.0, 0.1) 1 (0, 2)
OBS Stress 2
Month 12 4.8 4.6 -0.2 -4 (-5, -3)
OBS Stress 1 0.1)
Day 31 Transport
Lyphochek Month 12 4.8 4.8 0.0 (0.0, 0.0) 0 (0, 1)
OBS Stress 2
Unassayed
Day 0 Transport
CC lvl 1 Month 15 4.7 4.7 -0.0 (0.0, 0.0) -0 (-1, 0)
OBS Stress 1
Day 0 Transport
Month 15 4.7 4.7 0.0 (0.0, 0.0) 0 (0, 0)
OBS Stress 3
Month 15 4.7 4.6 -0.1 -2 (-3, -2)
OBS Stress 1 0.1)
Day 15 Transport
Month 15 4.7 4.7 0.0 (0.0, 0.0) 0 (0, 0)
OBS Stress 3
Month 15 4.7 4.4 -0.3 -6 (-7, -5)
OBS Stress 1 0.2)
Month 15 4.7 4.6 -0.1 -2 (-2, -2)
OBS Stress 3 0.1)
Day 0 Transport
Month 12 10.2 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
OBS Stress 1
Day 0 Transport
Month 12 10.2 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
OBS Stress 2
Day 15 Transport
Month 12 10.2 10.2 0.1 (0.0, 0.1) 1 (0, 1)
OBS Stress 1
Day 15 Transport
Month 12 10.2 10.4 0.2 (0.2, 0.2) 2 (2, 2)
OBS Stress 2
Month 12 10.2 10.1 -0.1 -1 (-1, -1)
OBS Stress 1 0.1)
Day 31 Transport
Lyphochek Month 12 10.2 10.3 0.1 (0.1, 0.2) 1 (1, 2)
OBS Stress 2
Unassayed
Day 0 Transport
CC lvl 2 Month 15 10.3 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
OBS Stress 1
Day 0 Transport
Month 15 10.3 10.2 -0.0 (-0.1, 0.0) -0 (-1, 0)
OBS Stress 3
Month 15 10.3 10.0 -0.3 -3 (-3, -2)
OBS Stress 1 0.2)
Day 15 Transport
Month 15 10.3 10.2 -0.1 (-0.1, 0.0) -1 (-1, 0)
OBS Stress 3
Day 31 Transport
Month 15 10.3 10.2 -0.1 (-0.1, 0.0) -1 (-1, 0)
OBS Stress 1
Day 31 Transport
Month 15 10.3 10.4 0.2 (0.1, 0.2) 2 (1, 2)
OBS Stress 3
a
a,b
NA indicates the baseline is either missing or equals to 0

ARCHITECT IRIS V1
Table III.A.34
(Transport + OBS)
Shift and % Shift
Urine Samples
Shifta % Shiftb
Test
Baseline Two- Two-
Sample Sub Test Point Mean Sided Sided
(mg/dL) 95% CL 95% CL
(mg/dL)
Month Day 0 Transport (-0.2,
10.0 9.9 -0.1 -1 (-2, 0)
12 OBS Stress 1 0.0)
Month Day 0 Transport (-0.4, -
10.0 9.7 -0.3 -3 (-4, -2)
10.0 9.8 -0.1 -1 (-2, -1)
10.0 10.0 0.0 0 (-1, 1)
10.0 9.5 -0.5 -5 (-6, -4)
Liquichek 10.0 9.8 -0.2 -2 (-3, -1)
Urine CC
ctrl lvl 1 9.4 9.2 -0.2 -2 (-3, -1)
9.4 9.1 -0.3 -3 (-4, -2)
9.4 9.2 -0.3 -3 (-4, -2)
9.4 9.4 0.0 0 (-1, 1)
9.4 9.2 -0.2 -3 (-4, -1)
Month Day 31 Transport
9.4 9.6 0.1 (0.1, 0.2) 1 (1, 2)
15 OBS Stress 3
20.9 20.7 -0.2 -1 (-2, 0)
20.9 20.6 -0.3 -2 (-3, -1)
20.9 20.7 -0.2 -1 (-2, 0)
20.9 21.1 0.2 (0.1, 0.4) 1 (0, 2)
12 OBS Stress 2
20.9 20.2 -0.6 -3 (-4, -2)
Liquichek 20.9 20.8 -0.1 -1 (-1, 0)
Urine CC
ctrl lvl 2 16.3 16.1 -0.2 -1 (-2, 0)
16.3 16.2 -0.1 -1 (-2, 0)
16.3 16.0 -0.3 -2 (-3, -1)
16.3 16.6 0.2 (0.1, 0.3) 1 (1, 2)
15 OBS Stress 3
16.3 16.1 -0.3 -2 (-2, -1)
16.3 16.5 0.2 (0.1, 0.3) 1 (1, 2)
15 OBS Stress 3

ARCHITECT IRIS V1
Table III.A.35
Condition: Packaging, Operations, Exposure Limits (POEL)
Shift and % Shift
Serum Samples
Shifta % Shiftb
Baseli
ne Test Point Two-
Test Value Two-Sided Value
Lot Sample Mean Mean Sided
Point (mg/dL) 95% CL (%)
(mg/d (mg/dL) 95% CL
L)
Lyphochek
POEL 4.8 4.8 -0.0 (0.0, 0.0) -0 (-1, 1)
Unassayed CC lvl 1
Reagent Lot 4
Lyphochek
POEL 10.3 10.3 0.1 (-0.1, 0.2) 1 (-1, 2)
Unassayed CC lvl 2
a
a,b

ARCHITECT IRIS V1
Table III.A.36
Condition: Packaging, Operations, Exposure Limits (POEL)
Shift and % Shift
Urine Samples
Shifta % Shiftb
Baseline Test Point Value Two-
Value Two-Sided
Lot Sample Test Point Mean Mean (mg/dL Sided
(%) 95% CL
(mg/dL) (mg/dL) ) 95% CL
Liquichek Urine (-0.4, -
POEL 10.3 10.0 -0.3 -3 (-4, -2)
CC LVL 1 0.2)
Reagent Lot 4
Liquichek Urine (-0.7, -
POEL 21.1 20.6 -0.5 -2 (-3, -1)
CC LVL 2 0.3)
a
a,b

ARCHITECT IRIS V1

04T13 - Uric Acid2 - Stability - IRIS V1

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04T13 - Uric Acid2 - Stability - IRIS V1

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Uric Acid2

Uric Acid2 Stability

Uric Acid2 Stability

II. Stability Dating and Kit Components

Uric Acid2 Reagent Kit (List No. 04T1320 / 04T1330)

Component List No. Expiration Dating

III. Reagent Developmental Stability Studies

A. Uric Acid2 Reagent Developmental Stability

Stability Conditions Number of Lots

The IU condition was performed to demonstrate the stability of the

Uric Acid2 Stability

The INV condition was performed to demonstrate stability of the

The POEL condition was performed to demonstrate stability of the

The Transport condition was performed to demonstrate reagent stability while

Uric Acid2 Stability

Uric Acid2 Stability

Uric Acid2 Stability

Additional Stability Lots

All reagents were stored continuously at the recommended storage

Reference Materials Information

Uric Acid2 Stability

The Clinical Chemistry Calibrator Serum Level 3 was reconstituted by pipetting

The BioRad Lyphochek Unassayed Chemistry Control (Human) Level 1 and

Intended Storage (IS)

Uric Acid2 Stability

At each subsequent time point, the process above was repeated.

Inverted Storage (INV)

At each subsequent time point, the INV-stressed reagent(s) were tested on

Packaging Operations Exposure Limits (POEL)

The POEL-stressed reagent(s) were tested on the ARCHITECT c8000

Transport Temperature Simulation (Transport)

Temperature Cycle Duration

Transport Stress 2 and 3 (Ambient Transport)

Uric Acid2 Stability

Transport Temperature Simulation (Transport) + On Board Storage (OBS)

At Month 15, the Transport-stressed reagent(s) from Transport Stress 1

The Transport-stressed reagent(s) were to be stored on board for a

On Board Storage (OBS)

Uric Acid2 Stability

The acceptability of the Uric Acid2 reagent stability was determined by

 a regression analysis for all IS, IU, and INV conditions

a. Stability Action Limit Evaluation/Results

Uric Acid2 Stability

Combined Stability Action Limit

Crossover evaluations are conducted when reference material substitutions

Uric Acid2 Stability

b. Regression Analysis Evaluation/Results

Stability Condition(s) Stability

The regression specification limits were met for each sample/reagent

Uric Acid2 Stability

OBS (Urine) Percent Shift / Shift from

Transport + OBS (Urine)

Uric Acid2 Stability

Uric Acid2 Stability

Sample: Lyphochek Unassayed CC Level 1 Sample: Lyphochek Unassayed CC Level 2

Uric Acid2 Stability

Sample: Lyphochek Unassayed CC Level 1 Sample: Lyphochek Unassayed CC Level 2

Uric Acid2 Stability

Sample: Lyphochek Unassayed CC Level 1 Sample: Lyphochek Unassayed CC Level 2

Uric Acid2 Stability

Sample: Lyphochek Unassayed CC Level 1 Sample: Lyphochek Unassayed CC Level 2

Uric Acid2 Stability