OneTouch Verio™Pro+ Blood Glucose Monitoring System:

Evaluation of a system designed for multi-patient use by

healthcare professionals

Key points Figure 1.

OneTouch Verio Pro+ Meter
® ™ 

■■  ccuracy and precision

A
In studies performed in the clinical environment
using capillary (fingertip), venous, and arterial
blood, or in the laboratory, the OneTouch Verio Pro+
® ™ Push-button
strip ejector
Blood Glucose Monitoring System (BGMS) has
shown high levels of accuracy and precision across
a wide range of blood glucose concentrations.
Accurate result
■■ I nterference in 5 seconds
The OneTouch Verio Pro+ BGMS is not sensitive
® ™

to 57 common endogenous and exogenous LCD color display

substances tested at their high normal or high
Highly durable
therapeutic concentrations.

■■  isinfection
D
The disinfection method recommended in the
product labeling for the OneTouch Verio Pro+
® ™

BGMS was shown to be effective at viral inactivation

without affecting the durability (functionality and
appearance) of the meter.
high-gloss surface and low-profile button that facilitate
cleanability.
The OneTouch Verio Test Strip (Figure 2) features a
® ™

side-fill sample application area and co-facial (opposing)

Introduction
The OneTouch Verio Pro+ Blood Glucose Monitoring
® ™
System is intended to be used by healthcare
professionals (HCPs) for the quantitative measurement
of glucose in fresh capillary (fingertip), venous, and
arterial whole blood samples as an aid to monitor
the effectiveness of blood glucose management. The
system is designed specifically for multi-patient blood
glucose testing with the HCP’s needs in mind. The
OneTouch Verio Pro+ BGMS provides glucose results
® ™
over the range of 20 to 600 mg/dL within a hematocrit
range of 20% to 60% (Table 1). Because the system
gold and palladium electrodes. The reagent chemistry
includes an FAD-dependent glucose dehydrogenase
enzyme (FAD-GDH); the high specificity of this enzyme
ensures that other sugars in the blood, such as maltose,
will not affect test results. In addition, the FAD-GDH
enzyme does not react with oxygen; test results are
insensitive to variations in blood oxygen levels.
The nine studies described in this paper (system
accuracy, clinical performance, hematocrit performance,
repeatability, intermediate precision, linearity, effect of
common anticoagulants, interference, and disinfection)
were conducted to evaluate the performance of the
OneTouch Verio Pro+ BGMS. Seven of these studies
® ™

does not need user calibration coding, it produces
reliable readings in fewer steps.
The ergonomic design of the OneTouch Verio Pro+
® ™
Meter (Figure 1) fits comfortably in the palm of the
hand and allows the user to easily and firmly hold the
meter. When the meter is turned on or a test strip is
inserted, the LCD color display with backlight comes on
automatically, enabling the user to easily read results
in low light conditions. The OneTouch Verio Pro+
® ™
Meter is equipped with safety features to control
infection transmitted through blood borne pathogens.
These features include a push-button strip ejector
that minimizes contact with used test strips and a
were conducted under institutional review board/ethics
committee–approved protocols with the informed
consent of the participants. (The intermediate precision
and disinfection studies did not involve human subjects
or samples from subjects.) System accuracy, clinical
performance, repeatability, and intermediate precision
evaluations were performed in a manner consistent with
the guidelines published by the International Organiza-
tion for Standardization (ISO).¹ Linearity was assessed
according to Clinical and Laboratory Standards Institute
(CLSI; formerly NCCLS) EP6-A.C Interference and anti-
coagulants were tested according to CLSI guidelines
EP7-A2D and EP14-A2,E respectively.
Table 1.
OneTouch Verio Pro+ BGMS specifications
® ™ 

Feature Specification

Operating principle FAD-GDH enzyme chemistry with electrochemical (amperometry) detection

Sample types Capillary (fingertip), venous, and arterial whole blood
Calibration Plasma-equivalent
Coding Calibration codes not required
Result range 20 to 600 mg/dL
Operating temperature 6°C  to 44°C 
(43°F  to 111°F)
Altitude Up to 3048 meters
(10,000 feet)
Hematocrit range 20% to 60%
Test time 5 seconds
Sample volume 0.4 µL

Figure 2.
OneTouch Verio Test Strip
® ™

A. Assembled view B. Exploded view

Sample application area

Gold electrode
Spacer layer
Sensing chamber
Palladium electrode
Reagent chemistry

Meter connection points

2
System accuracy
The ISO criterion for acceptable system accuracy is that Table 2.
Ö 95% of BGMS results fall within specified error toler- OneTouch Verio Pro+ BGMS system accuracy (n = 600)
® ™

ances. The OneTouch Verio Pro+ system accuracy study

® ™

presented in this section assessed accuracy according A. Overall system accuracy according to ISO and
to two specifications for error tolerance: tighter specifications
•  ISO system accuracy specification ISO specification
Individual glucose results are considered accurate
Within ± 15 mg/dL 598 of 600
if they fall within ± 15 mg/dL of the reference result
or ± 20% of reference 99.7%
at glucose concentrations < 75 mg/ dL or within ± 20%
at glucose concentrations Ö 75  mg/dL. Tighter specification
•  Tighter system accuracy specification Within ± 12 mg/dL 591 of 600
Individual glucose results are considered accurate or ±15% of reference 98.5%
if they fall within ± 12 mg/dL of the reference result
at glucose concentrations < 80 mg/dL or within ± 15%
at glucose concentrations Ö 80  mg/dL. B. System accuracy according to ISO accuracy intervals

Glucose < 75 mg/dL Glucose Ö 75 mg/dL

Methods
± 10 ± 15
•  Testing was performed by trained staff using fingertip mg/dL mg/dL ± 10% ± 15% ± 20%
blood samples from 100 subjects.
115/120 119/120 439/480 475/480 479/480
•  The blood glucose concentrations of samples were 95.8% 99.2% 91.5% 99.0% 99.8%
distributed according to the ISO system accuracy
concentration categories; hematocrits ranged from
27.3% to 50.7%.
C. System accuracy according to tighter accuracy intervals
•  For each subject, six OneTouch Verio Pro+ BGMS
® ™

tests (duplicate tests with each of three test strip lots) Glucose < 80 mg/dL Glucose Ö 80 mg/dL
were performed from a single fingertip lancing. ± 10 ± 12
mg/dL mg/dL ± 10% ± 15%
•  Comparison testing was performed before and
after OneTouch Verio Pro+ BGMS testing using the
® ™
127/132 128/132 429/468 463/468
YSI 2300 STAT Plus Biochemistry Analyzer (YSI, Inc., 96.2% 97.0% 91.7% 98.9%
™

Yellow Springs, Ohio, USA).

•  The number and percentage of accurate results
(per ISO and tighter specifications) were calculated.
Figure 3. 
OneTouch Verio Pro+ BGMS system accuracy:
® ™ 

Results
Bias plot of Verio Pro+ Meter results (n = 600)
™

•  Overall accuracy (Table 2A, Figure 3): 99.7%

(598/600) of OneTouch Verio Pro+ BGMS results
® ™

were within the ISO error tolerance boundaries, and

98.5% (591/600) of results were within the tighter
error tolerance boundaries.
•  Accuracy at low glucose concentrations: 95.8%
(115/120) of OneTouch Verio Pro+ BGMS results
® ™

were within ± 10 mg/dL of reference values

< 75 mg/dL (Table 2B), and 96.2% (127/132) of
OneTouch Verio Pro+ BGMS results were within
® ™

± 10 mg/dL of reference values < 80 mg/dL (Table 2C).

•  Linear regression analysis results: slope = 0.98; ISO error tolerance boundaries
y-intercept = 2.3 mg/dL; standard error (S y.x ) = Tighter error tolerance boundaries
9.8 mg/dL; r² = 0.99 (n = 600).

3
Clinical performance
Methods Figure 4.
OneTouch Verio Pro+ BGMS clinical accuracy
® ™ 

•  Capillary samples (n = 189; hematocrit range 23% to

(per ISO specification): Bias plots with ISO error
52%) and venous samples (n = 177; hematocrit range tolerance boundaries
23% to 55%) were drawn from consented subjects
at three clinical sites in the United Kingdom. Arterial
samples (n = 67; hematocrit range 23% to 60%) A. Capillary samples (n = 189 results)
were obtained at the same sites, plus one site in
the United States, from patients with an existing
physician order for blood testing.
•  Each capillary and venous sample was tested once
on the OneTouch Verio Pro+ BGMS by an HCP using
® ™

a test strip from one of three lots. Arterial samples

were tested in triplicate by HCPs using all three test
strip lots. Note: One of the 201 arterial tests resulted
in an error message (insufficient blood sample),
reducing the number of evaluable arterial results
to 200.
•  Capillary sample was applied to the test strip directly
from the subject’s fingertip; venous sample was B. Venous samples (n = 177 results)
applied with a transfer pipette; and arterial sample
was applied from a syringe.
•  A technician performed comparison testing of each
sample with the YSI 2300.
•  The number and percentage of accurate results (per ISO
specification) were calculated for each sample type.
•  Consensus error grid analysisF and linear regres-
sion analysis were performed on the OneTouch ®

Verio Pro+ BGMS results for each sample type.

™

Results
•  Accuracy (Figure 4): Across all sample types, 99.8%
C. Arterial samples (n = 200 results)
(565/566) of OneTouch Verio Pro+ BGMS results
® ™

were within the ISO error tolerance boundaries. The

largest bias observed for an individual OneTouch ®

Verio Pro+ BGMS result was –20.3% at 150.5 mg/dL.

™

•  Consensus error grid analysis (Table 3, Figure 5):

100% of OneTouch Verio Pro+ BGMS capillary and
® ™

venous results and 97.5% of the arterial results were

in zone A (no effect on clinical action).
•  Linear regression analyses are summarized in Table 4.

4
Table 3. Figure 5.
OneTouch Verio Pro+ BGMS clinical performance: OneTouch Verio Pro+ BGMS clinical performance:
® ™  ® ™ 

Consensus error grid analysis Consensus error grids

Zone Capillary Venous Arterial A. Capillary samples (n = 189 results)

A 189 177 195
(100%) (100%) (97.5%)
B — — 5
(2.5%)
C — — —
D — — —
E — — —

zone definitions
Zone A: No effect on clinical action
Zone B: Altered clinical action — little or no effect on clinical outcome
Zone C: Altered clinical action — likely to affect clinical outcome
Zone D: Altered clinical action — could have a significant medical risk
Zone E: Altered clinical action — could have dangerous consequences

B. Venous samples (n = 177 results)

Table 4.
OneTouch Verio Pro+ BGMS clinical performance:
® ™ 

Linear regression analysis

Statistic Capillary Venous Arterial

n 189 177 200
slope 0.96 0.96 0.91
y-intercept (mg/dL) 9.1 8.2 7.5
rB 0.98 0.99 0.96
Std. error (Sy.x ) (mg/dL) 10.4 8.5 7.4

C. Arterial samples (n = 200 results)

5
Hematocrit performance
Methods Figure 6.
OneTouch Verio Pro+ BGMS hematocrit performance:
® ™ 

•  Each of three donor venous blood samples was

Mean bias at each glucose and hematocrit level
adjusted in the laboratory to five target hematocrit
levels ranging from 20% to 60% and five target Bias is expressed as mg/dL for the two lowest
glucose levels ranging from 30 to 560 mg/dL. glucose levels and percentage for the higher levels.
Each bar represents the mean bias of 108 results.
•  Technicians performed OneTouch Verio Pro+
® ™

BGMS tests using 12 OneTouch Verio Pro+ Meters

® ™

and three lots of OneTouch Verio Test Strips and

® ™

comparison testing with the YSI 2700 SELECT ™

Glucose Analyzer (YSI, Inc., Yellow Springs, Ohio,

USA) for each combination of donor, hematocrit,
and glucose level.
•  The number and percentage of accurate results
(per ISO specification) were calculated for all results.
•  The mean bias to plasma glucose concentration as
measured by the YSI 2700 was calculated for each
combination of glucose level and hematocrit (all
donors, meters, and test strip lots).

Results

•  For all donors, hematocrits, glucose levels, and

test strip lots, 100% (2700/2700) of OneTouch ®

Verio Pro+ BGMS results were within the ISO error

™

tolerance boundaries.
•  The largest bias observed for an individual
OneTouch Verio Pro+ BGMS result was –17.8%
® ™

at 61% hematocrit and 560 mg/dL glucose.

•  At each hematocrit level, mean bias (Figure 6)
trended from slightly positive to slightly negative
as glucose concentration increased.

6
Repeatability Intermediate precision
Methods Methods
•  A venous blood sample (hematocrit 41.5%) was •  The testing procedure involved three control solution
adjusted in the laboratory to five target glucose levels (low, mid, and high), three lots of OneTouch ®

levels ranging from 42 to 330 mg/dL. Verio Test Strips, and 30 OneTouch Verio Pro+ Meters
™ ® ™

•  The testing procedure involved three lots of (10 meters per test strip lot).
OneTouch Verio Test Strips and 30 OneTouch
® ™ ®
•  Testing was executed in the laboratory by multiple
Verio Pro+ Meters (10 meters per test strip lot).
™
operators over a 10-day period.
•  Testing (10 replicates per meter at each glucose
•  On each day of testing, duplicate tests were performed
level) was executed by a single operator on one day.
with each meter at each control solution level.
•  For each glucose level, the pooled mean glucose,
pooled standard deviation (SD), and pooled •  For each control solution level, the mean glucose (all
coefficient of variation (CV) were calculated. test strip lots, meters, and days), SD (pooled for the test
strip lots), and CV were calculated.
Results
Results
•  All pooled CV values were ≤2.55% (Table 5),
indicating that from strip to strip, the OneTouch® •  The pooled CV values range from 1.53% to 2.11%
Verio Pro+ BGMS provided repeatable results across
™ (Table 6), demonstrating that the OneTouch ®

a wide range of blood glucose levels. Verio Pro+ BGMS provides reproducible test results
™

with control solution.

Table 5.
Table 6.
OneTouch Verio Pro+ BGMS repeatability:
® ™ 

OneTouch Verio Pro+ BGMS intermediate precision:

® ™ 

Pooled data for three test strip lots

Pooled data for three test strip lots
(n = 300 for each glucose level)
(n = 600 for each control solution level)

OneTouch Verio  Pro+

® ™

OneTouch Verio  Pro+

® ™

mean glucose SD CV
(mg/dL) (mg/dL) (%) mean glucose SD CV
(mg/dL) (mg/dL) (%)
43
42.9 1.09
1.09 2.55
2.55 38 0.80 2.11
97.4
97 1.83
1.83 1.88
1.88
128.6 2.44 1.90 117 1.79 1.53
129
193.7 2.44
3.91 1.90
2.02 339 5.94 1.75
343.2 7.48 2.18
194 3.90 2.01
343 7.48 2.18

7
Linearity
Methods
•  Venous blood samples collected from each of nine
donors (hematocrit range 37.1% to 43.3%) were
adjusted in the laboratory to eight glucose levels
ranging from approximately 20  to 700 mg/dL.
Effect of common anticoagulants
Methods
•  A laboratory study was performed to evaluate
the potential matrix effects of four common
anticoagulants (lithium heparin, sodium heparin,
potassium EDTA, and sodium citrate) on OneTouch ®

Verio Pro+ BGMS accuracy.

™

•  Adjusted samples were tested (in duplicate)

on each of eight OneTouch Verio Pro+ Meters
® ™
•  Four venous blood samples from each of 22 donors
(glucose response range opened to allow testing at (hematocrit range 37.2% to 45.0%) were collected in
700 mg/dL) with three OneTouch Verio Test Strip
® ™
separate tubes containing one of the anticoagulants.
lots, generating 432 results per blood glucose level.
•  Aliquots of each sample were adjusted to target
•  Comparison testing of each sample was performed plasma glucose levels of approximately 30, 65, 240,
with the YSI 2300. and 560 mg/dL.
•  Weighted linear regression of OneTouch Verio Pro+
® ™
•  Unadjusted (native) samples and each adjusted
BGMS ( y-axis) vs. YSI 2300 ( x-axis) was performed, aliquot were tested using five OneTouch Verio Pro+
® ™

with weights proportional to the inverse of the YSI Meters and three OneTouch Verio Test Strip lots.
® ™

2300 glucose value.

•  Comparison testing of each adjusted aliquot was
performed with the YSI 2300.
Results
•  Each OneTouch Verio Pro+ BGMS result was
® ™

•  Weighted linear regression analysis: slope = 0.99; evaluated for accuracy according to the ISO
y-intercept = 2.2 mg/dL; r² = 0.997 (n = 3,456). specification described above.

Results
•  At least 99.6% accuracy was achieved with each
anticoagulant across the entire glucose range tested
(Table 7).

Table 7.
OneTouch Verio Pro+ BGMS accuracy (per ISO
® ™ 

specification): Effect of anticoagulants

Anticoagulant Accurate results

Lithium heparin 1649 of 1650
(99.9%)
Sodium heparin 1646 of 1650
(99.8%)
Potassium edta 1644 of 1650
(99.6%)
Sodium citrate 1650 of 1650
(100%)

8
 Interference
Methods Table 8.
OneTouch Verio Pro+ BGMS: Maximum allowed
® ™ 

•  A laboratory study was performed with venous blood

concentrations of 23 common interfering substances
samples to evaluate the effects of 59 potentially in-
terfering substances on OneTouch Verio Pro+ BGMS
® ™

performance. A. Endogenous substances

•  In the initial phase of testing (paired-difference High normal Maximum allowed

screening), potential interfering substances were concentration concentration
Compound (mg/dL) (mg/dL)
tested at the highest recommended concentration
(“worst case”). Ascorbic acid
Ascorbic acid 2.0
2 6.0
5.71
5.71
Bilirubin
Bilirubin 1.20
1.20 18.97
20.0
18.97
•  Any substance that failed the screening phase was Glutathione 0.535 64.85
subjected to dose-response testing to determine the Glutathione 0.535 68.4
64.85
Uric acid 8 9.55
lowest concentration at which interference occurred. Uric acid
Cholesterol 8.0
200 9.97
750.9
9.55
•  The saccharide xylose was evaluated directly by the Creatinine
Cholesterol 1.3
200 4.74
700
750.9
dose-response method, based on prior knowledge of Hemoglobin 200 200
Creatinine 1.3 5.1
4.74
its interfering effect. Lactic acid 19.8 56.33
Hemoglobin
Triglycerides 200
250 200
3331
Urea
Lactic acid 85.8
19.8 249.10
59.4
56.33
Results
Triglycerides 250 3000
331
•  The accuracy of the OneTouch Verio Pro+ BGMS was
® ™

Urea 85.8 257.4

249.10
not compromised by 57 of the 59 endogenous and
exogenous interfering substances tested at or above
their high normal or high therapeutic concentrations.
The results for 23 of the most common interfering B. Exogenous substances
substances are listed in Tables 8A and 8B.*
High therapeutic Maximum allowed
•  The exceptions are xylose, which is sometimes used concentration concentration
clinically to diagnose nutrient malabsorption in Compound (mg/dL) (mg/dL)
the small intestine,G and pralidoxime iodide (PAM), Acetaminophen
Acetaminophen 3.0
3 17.8
16.88
16.88
which is used to combat poisoning by organophos- Dopamine 0.03 0.08
Dopamine 0.03 0.09
0.08
phates or acetylcholine esterase inhibitors. The Atorvastatin 2.67 7.11
OneTouch Verio Pro+ BGMS should not be used
® ™ Atorvastatin 2.67 8.0
7.11
Digoxin 0.203 μg/dL 0.57 μg/dL
when either of these interfering substances is known Digoxin
Dobutamine 2.03×10 -E
4.67 μg/dL
0.203 6.1×10
11.84
0.57 -E
μg/dL
or suspected to be in the whole blood sample. Ephedrine
Dobutamine 0.01
4.67 0.19
14
11.84
Epinephrine 0.032 0.092
Ephedrine 0.01 0.2
0.19
Salicylate 30 57.48
* The other 34 compounds that were shown to not compromise Epinephrine
Warfarin 0.032
0.31 0.096
0.95
2
theophylline ampicillin, atenolol, cefazolin,
accuracy are aminophylline,
chlorpropamide, cimetidine, erythromycin, ezetimibe, fenofibrate, Galactose
Salicylate 5
30 60.39
60
57.48
furosemide, gentamicin, gentisic acid, glimepiride, glipizide, Lactose 0.5 3.93
Warfarin 0.31 1.0
0.95
glyburide, hydralazine, hydrochlorothiazide, hydrocodone, Maltose 120 363.6
ibuprofen, insulin, L-dopa, lidocaine, lisinopril, mannitol, Galactose
Sucrose 5.0
2670 15
5142
60.39
metformin, methyldopa, phenytoin, pioglitazone, procainamide,
quinidine, simvastatin, tetracycline, tolazamide, and tolbutamide. Lactose 0.5 4.1
3.93
Maltose 120 360
363.6
Sucrose 2670 5430
5142

9
 Disinfection Conclusions
The accuracy, hematocrit performance, precision, and
Methods linearity of the OneTouch Verio Pro+ Blood Glucose
® ™

•  The U.S. Food and Drug Administration requires
that the efficacy of disinfectants used to clean and
disinfect the exterior surfaces of blood glucose
monitoring systems be validated against hepatitis B
virus utilizing the actual materials that make up the
components of the system.H
Monitoring System have been demonstrated in labora-
tory and clinical studies. In both the system accuracy
and the clinical performance studies, accuracy levels
exceeded the widely recognized ISO criteria. The per-
formance at low glucose concentrations was consistent
with the high level of performance across all glucose
concentrations. The OneTouch  Verio Pro+ BGMS
® ™

•  A 10% bleach solution (Ultra Clorox Germicidal

®

produced at least 99.6% accurate results with venous

Bleach, EPA Reg. No. 67619-8; labeled as effective samples collected in four different anticoagulant tubes.
against human hepatitis B) was selected as the The OneTouch Verio Pro+ BGMS is not sensitive to
® ™

disinfection method for the OneTouch Verio Pro+

® ™
Meter. (A 10% bleach solution is equivalent to 0.55%
[5500 ppm] sodium hypochlorite.)
•  A disinfection study conducted at an independent
microbiology and virology laboratory was designed
to simulate the actual conditions under which
the disinfectant is used. The virucidal efficacy of
57 common interfering substances at their high normal
or high therapeutic concentrations. The disinfection
method recommended in the product labeling was
shown to be effective, which is important for a system
that is designed to support multi-patient testing in an
HCP environment. Studies demonstrating the equiva-
lence of OneTouch Verio System Meters* suggest that
® ™

the bleach solution was tested against surrogate all meters using OneTouch Verio Test Strips would
® ™

hepatitis B virus on three lots of the three materials show similar levels of performance.
that make up the contactable surfaces of the meter.
The materials were wiped with bleach solution; after
a one-minute exposure time, the materials were
tested for viral titer (along with positive and negative
controls).
•  A separate procedure evaluated the durability
of OneTouch Verio Pro+ Meters subjected to the
® ™

disinfection method.

Results
•  The disinfection method recommended in the
OneTouch Verio Pro+ BGMS product labeling was
® ™

effective. Complete inactivation of the surrogate

hepatitis B virus was achieved on the materials that
constitute the surfaces of the OneTouch Verio Pro+
® ™

Meter.
•  Functionality and appearance of the OneTouch ®

Verio Pro+ Meter were not affected by the disinfec-

™

tion method.

* OneTouch Verio System Meters include OneTouch Verio , OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+.
® ™ ® ™ ® ™ ® ™ ® ™

10
References
1. International Organization for Standardization. In vitro
diagnostic test systems—requirements for blood-glucose
monitoring systems for self-testing in managing diabetes
mellitus. ISO International Standard 15197:2003.
2. NCCLS. Evaluation of the Linearity of Quantitative
Measurement Procedures: A Statistical Approach;
Approved Guideline. NCCLS document EP6-A (ISBN
1-56238-498-8). NCCLS, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898, USA, 2003.
3. Clinical and Laboratory Standards Institute. Interference
Testing in Clinical Chemistry; Approved Guideline—Second
Edition. Clinical and Laboratory Standards Institute
document EP7-A2 (ISBN 1-56238-584-4). Clinical and
Laboratory Standards Institute, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898, USA,
2005.
4. Clinical and Laboratory Standards Institute. Evaluation
of Matrix Effects; Approved Guideline—Second Edition.
Clinical and Laboratory Standards Institute document
EP14-A2 (ISBN 1-56238-561-5). Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898, USA, 2005.
5. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new
consensus error grid to evaluate the clinical significance
of inaccuracies in the measurement of blood glucose.
Diabetes Care. 2000;23(8):1143– 1148.
6. Jacobs, DS, et al. d-Xylose absorption test. In Laboratory
Test Handbook, Lexi-Comp Inc., Hudson, Ohio, USA, 1996,
pp. 369–371.
7. U.S. Food and Drug Administration Letter Dated
September 17, 2010. Letter to Manufacturers of Blood
Glucose Monitoring Systems Listed with the FDA. http://www.
fda.gov/MedicalDevices/ProductsandMedicalProcedures/
InVitroDiagnostics/ucm227935.htm.

11
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