Siemens Healthcare Diagnostics Products GmbH Certificate of Analysis

Emil-von-Behring-Str. 76
P.O.
35041 Marburg
Material: Commission-No.
Germany
10446442
Kit-Lot: Customer-Order-No.
572105
Total lot size: Customer-No.
11222 PC
Delivery amount: Storage at:
+02°C to 08°C
Release date:
2023-12-06
Customer
Manufacturing date: Expiration date:
To whom it may concern
2023-09-19 2025-09-18
Legal Material Number:
OUHP29
Released by:
Mike Lamsfuss

Material: 10446442
Thromborel S
Inspection ID-No.: 400000672350
_______________________________________________________________________

Kit components:
Level Material-No. Lot Release date
Material-Name
_______________________________________________________________________
0010 11530342 572105 2023-10-30
Thromborel S
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Print date 2023-12-06
Material: 10446442
Thromborel S
Inspection ID-No.: 400000672350
_______________________________________________________________________

Inspection results:
Material-No. Lot
_______________________________________________________________________

11530342 572105
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

12.6 S - 14.4 S 10.6 S

Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

80.7 % - 98.3 % 65.5 %

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

21.9 S - 25.7 S 17.1 S

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

32.7 % - 42.7 % 28.5 %
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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: 10446442
Thromborel S
Inspection ID-No.: 400000672350
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

11530342 572105
Thromborel S

Result Unit Assigned Value Upper Limit Lower Limit

66.8 S - - 44.4 S

Standard Human Plasma

Result Unit Assigned Value Upper Limit Lower Limit

12.4 S - 14.0 S -

Standard Human Plasma (1+1)

1+1 dilution with NaCl solution

Result Unit Assigned Value Upper Limit Lower Limit

17.3 S - - -

Difference

Result Unit Assigned Value Upper Limit Lower Limit

4.9 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

12.6 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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Print date 2023-12-06
Material: 10446442
Thromborel S
Inspection ID-No.: 400000672350
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

11530342 572105
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

2.9 % - 10.0 % -
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_______________________________________________________________________

_______________________________________________________________________

Test material: Control Plasma N

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark 507932

Test material: Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark
556741
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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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