Siemens Healthcare Diagnostics Products GmbH Certificate of Analysis

Emil-von-Behring-Str. 76
P.O.
35041 Marburg
Material: Commission-No.
Germany
10446499
Kit-Lot: Customer-Order-No.
00606
Total lot size: Customer-No.
322 PC
Delivery amount: Storage at:
+02°C to 08°C
Release date:
2021-09-24
Customer
Manufacturing date: Expiration date:
To whom it may concern
2021-06-30 2023-06-29
Legal Material Number:
OUVV15
Released by:
Stefan Barth

Material: 10446499
Berichrom Protein C
Inspection ID-No.: 400000498159
_______________________________________________________________________

Kit components:
Level Material-No. Lot Release date
Material-Name
_______________________________________________________________________
0010 11523860 546369 2021-08-13
Protein C Activator
0020 11530375 563403 2021-07-20
HEPES-PLG./BC-PROT.C 30ML
0030 11530374 552928 2021-08-09
SUBSTR.REAG./BC-PR.C F.3ML
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Print date 2021-09-27
Material: 10446499
Berichrom Protein C
Inspection ID-No.: 400000498159
_______________________________________________________________________

Inspection results:
Material-No. Lot
_______________________________________________________________________

10446499 00606
Berichrom Protein C
_______________________________________________________________________
_______________________________________________________________________

Activity
Determination of the Protein C activity with isotonic saline solution at 405 nm on a tempered (+37°C) photometer.
Test scheme according instruction for use.
_______________________________________________________________________

Isot. NaCl solution

Result Unit Assigned Value Upper Limit Lower Limit

0.000 - 0.005 -
_______________________________________________________________________
_______________________________________________________________________

Functional test on BCS (XP) System

Establish the calibration curve with Standard Human Plasma and test the recovery from controls in 3fold
determination on BCS / BCS XP System.
_______________________________________________________________________

Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

95.6 % - 124.0 % 82.0 %

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

32.0 % - 43.0 % 25.0 %
_______________________________________________________________________
_______________________________________________________________________

Sensitivity
a) Determination of the Protein C sensitivity with Standard Human Plasma at 405 nm on a tempered (+37°C)
photometer.
b) Determination of the Protein C sensitivity with isotonic saline solution ati 405 nm on a tempered (+37°C)
photometer.
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Print date 2021-09-27
Material: 10446499
Berichrom Protein C
Inspection ID-No.: 400000498159
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

10446499 00606
Berichrom Protein C

Standard Human Plasma

Result Unit Assigned Value Upper Limit Lower Limit

0.177 - - 0.150

Isot. NaCl solution

Result Unit Assigned Value Upper Limit Lower Limit

0.000 - 0.005 -
_______________________________________________________________________
_______________________________________________________________________

Specificity
Determination of the Protein C activity of controls and calculation of the deviation of the target value.
_______________________________________________________________________

Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

95.3 % - - -

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

32.5 % - - -
_______________________________________________________________________
_______________________________________________________________________

Reproducibility / CPN
Determination of the Protein C activity of Control Plasma N in 3fold determination and calculation of the cv.
_______________________________________________________________________

CV
Coefficient of variation

Result Unit Assigned Value Upper Limit Lower Limit

1.1 % - 10.0 % -

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Print date 2021-09-27
Material: 10446499
Berichrom Protein C
Inspection ID-No.: 400000498159
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

10446499 00606
Berichrom Protein C
_______________________________________________________________________
_______________________________________________________________________

Reproducibility / CPP
Determination of the Protein C activity of Control Plasma P in 3fold determination and calculation of the cv.
_______________________________________________________________________

CV
Coefficient of variation

Result Unit Assigned Value Upper Limit Lower Limit

2.1 % - 10.0 % -
_______________________________________________________________________

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
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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Print date 2021-09-27