Siemens Healthcare Diagnostics Products GmbH Certificate of Analysis

Emil-von-Behring-Str. 76
P.O.
35041 Marburg
Material: Commission-No.
Germany
10446015
Kit-Lot: Customer-Order-No.
00664
Total lot size: Customer-No.
515 PC
Delivery amount: Storage at:
+02°C to 08°C
Release date:
2021-10-07
Customer
Manufacturing date: Expiration date:
To whom it may concern
2021-08-19 2022-11-18
Legal Material Number:
OPFH05
Released by:
Stefan Barth

Material: 10446015
INNOVANCE Antithrombin
Inspection ID-No.: 400000505502
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Kit components:
Level Material-No. Lot Release date
Material-Name
_______________________________________________________________________
0010 11530087 547759 2021-09-03
INNOVANCE Antithrombin Reagent
0020 11530091 549451 2021-09-13
INNOVANCE Antithrombin Substrate
0030 11530089 548656 2021-08-26
INNOVANCE Antithrombin Buffer
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Material: 10446015
INNOVANCE Antithrombin
Inspection ID-No.: 400000505502
_______________________________________________________________________

Inspection results:
Material-No. Lot
_______________________________________________________________________

10446015 00664
INNOVANCE Antithrombin
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_______________________________________________________________________

Sensitivity
Establish a calibration curve with Standard Human Plasma on the BCS System according to current INNOVANCE
Antithrombin application sheet and determination the absorbance of different concentration levels.
Specification:
When a blank of 0% Antithrombin is measured on BCS system, the absorbance in mA/min should be between
2000 and 3500 mA/min.
When a plasma of 60% Antithrombin is measured on BCS system, the absorbance in mA/min should be between
1000 and 1800 mA/min.
When a plasma of 150% Antithrombin is measured on BCS system, the absorbance in mA/min should be between
200 and 900 mA/min.
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0%

Result Unit Assigned Value Upper Limit Lower Limit

2717 mE/min - 3500 mE/min 2000 mE/min

60%

Result Unit Assigned Value Upper Limit Lower Limit

1541 mE/min - 1800 mE/min 1000 mE/min

150%

Result Unit Assigned Value Upper Limit Lower Limit

628 mE/min - 900 mE/min 200 mE/min
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Specificity
Determination of the activity [% of norm] for controls.
Specification:
Target value +/- 10% for normal sample and sample in the decision range; target value +/- 20% for pathological
sample.
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Material: 10446015
INNOVANCE Antithrombin
Inspection ID-No.: 400000505502
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

10446015 00664
INNOVANCE Antithrombin

Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

95.6 % - 107.8 % 88.2 %

Control Plasma N (75%)

Diluted with INNOVANCE Antithrombin Buffer.

Result Unit Assigned Value Upper Limit Lower Limit

72.0 % - 82.5 % 67.5 %

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

34.1 % - 40.8 % 27.2 %
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Reproducibility
Measuring two different controls the coefficient of variation (CV) should be less than 10% when measuring five
times within run.
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CV CPN
Coefficient of variation for Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

2 % - 10 % -

CV CPP
Coefficient of variation for Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

3 % - 10 % -
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This document was generated by means of electronic data system, which was designed and
validated to comply with the FDA21 CFR Part 11 electronic records and signature. This

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document indicates an electronic signature for batch release.
This lot has been tested and approved for release and shipment by the responsible Siemens
Healthcare Diagnostics Quality department.

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