Siemens Healthcare Diagnostics Products GmbH Certificate of Analysis

Emil-von-Behring-Str. 76
P.O.
35041 Marburg
Material: Commission-No.
Germany
10446445
Kit-Lot: Customer-Order-No.
568038
Total lot size: Customer-No.
4632 PC
Delivery amount: Storage at:
+02°C to 08°C
Release date:
2021-09-30
Customer
Manufacturing date: Expiration date:
To whom it may concern
2021-06-25 2023-06-24
Legal Material Number:
OUHP49
Released by:
Stefan Barth

Material: 10446445
Thromborel S
Inspection ID-No.: 400000491390
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Kit components:
Level Material-No. Lot Release date
Material-Name
_______________________________________________________________________
0010 11530343 568038 2021-07-14
Thromborel S
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Material: 10446445
Thromborel S
Inspection ID-No.: 400000491390
_______________________________________________________________________

Inspection results:
Material-No. Lot
_______________________________________________________________________

11530343 568038
Thromborel S
_______________________________________________________________________
_______________________________________________________________________

Activity
Creation of a reference curve with PT Multi Calibrator 1 to 5 on the BCS/BCS XP System, according to
Reference Guide and Instruction For Use (IFU). Verification of the reference curve with control plasma.
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Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

12.4 S - 14.4 S 10.6 S

Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

93.3 % - 101.3 % 67.5 %

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

22.1 S - 26.5 S 17.7 S

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

36.1 % - 43.2 % 28.8 %
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Sensitivity
Applying the reference curve from the Activity, the PT will be determined by using Coagulation Factor VII -
deficient plasma, Standard Human Plasma and Standard Human Plasma diluted 1+1 with isotonic NaCl solution.
Calculation of the different between Standard Human Plasma and Standard Human Plasma diluted 1+1 with isotonic
NaCl solution.
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Coagulation Factor VII

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Material: 10446445
Thromborel S
Inspection ID-No.: 400000491390
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

11530343 568038
Thromborel S

Result Unit Assigned Value Upper Limit Lower Limit

67.9 S - - 46.0 S

Standard Human Plasma

Result Unit Assigned Value Upper Limit Lower Limit

12.2 S - 14.0 S -

Standard Human Plasma (1+1)

1+1 dilution with NaCl solution

Result Unit Assigned Value Upper Limit Lower Limit

17.0 S - - -

Difference

Result Unit Assigned Value Upper Limit Lower Limit

4.8 S - - 4.5 S
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Specificity
Verification of the activity from Control plasma N with 9 vials Thromborel S and calculation the different from the
assigned value.
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Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

12.4 S - - -

Deviation to the nominal value of CPN

Result Unit Assigned Value Upper Limit Lower Limit

0.8 % - 15.0 % -15.0 %

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Material: 10446445
Thromborel S
Inspection ID-No.: 400000491390
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

11530343 568038
Thromborel S
_______________________________________________________________________
_______________________________________________________________________

Reproducibility
Verification of the activity from Control plasma N with 9 vials Thromborel S and calculation of the cv.
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CV
Coefficient of variation

Result Unit Assigned Value Upper Limit Lower Limit

2.6 % - 10.0 % -
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_______________________________________________________________________

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Test material: Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark 507788

Test material: Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark
556724
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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
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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