Fibrinogen Calibrator Kit

FIBRINOGEN CALIBRATOR

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for the fibrinogen assay

Intended Use
FIBRINOGEN CALIBRATOR 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the
method of Clauss1 using Siemens Healthineers Multifibren® U.

Reagents
Reagent Description Storage Stability

Fibrinogen Calibrator Kit

FIBRINOGEN CALIBRATOR

CALIBRATOR 1 Lyophilized reagent containing: 2–8 °C 15–25 °C:

• human plasmaa May be used up to the reconstituted,
• Buffer expiry date indicated on 4 h;
• Stabilizer: the label if stored −20 °C:
unopened. reconstituted,
• HEPES
4 weeks
CALIBRATOR 2 Lyophilized reagent containing: 2–8 °C 15–25 °C:
• human plasmaa May be used up to the reconstituted,
• Buffer expiry date indicated on 4 h;
• Stabilizer: the label if stored −20 °C:
unopened. reconstituted,
• HEPES
4 weeks
CALIBRATOR 3 Lyophilized reagent containing: 2–8 °C 15–25 °C:
• human plasmaa May be used up to the reconstituted,
• Buffer expiry date indicated on 4 h;
• Stabilizer: the label if stored −20 °C:
unopened. reconstituted,
• HEPES
4 weeks
CALIBRATOR 4 Lyophilized reagent containing: 2–8 °C 15–25 °C:
• human plasmaa May be used up to the reconstituted,
• Buffer expiry date indicated on 4 h;
• Stabilizer: the label if stored −20 °C:
unopened. reconstituted,
• HEPES
4 weeks

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Reagent Description Storage Stability

CALIBRATOR 5 Lyophilized reagent containing: 2–8 °C 15–25 °C:
• human plasmaa May be used up to the reconstituted,
• Buffer expiry date indicated on 4 h;
• Stabilizer: the label if stored −20 °C:
unopened. reconstituted,
• HEPES
4 weeks
CALIBRATOR 6 Lyophilized reagent containing: 2–8 °C 15–25 °C:
• human plasmaa May be used up to the reconstituted,
• Buffer expiry date indicated on 4 h;
• Stabilizer: the label if stored −20 °C:
unopened. reconstituted,
• HEPES
4 weeks
a
from pooled plasma collected from selected healthy blood donor
FIBRINOGEN CALIBRATOR consist of pooled plasma from selected, healthy donors, that has been diluted
with buffer solution or supplemented with purified fibrinogen and are stabilized with Hepes Buffer
Solution and lyophilized.
Once reconstituted, FIBRINOGEN CALIBRATOR can be frozen and thawed once. They must be frozen as
rapidly as possible in a well-closed container. Thawing is to be accomplished at 37 °C within a
maximum of 10 minutes.
FIBRINOGEN CALIBRATOR should then not be exposed to 15 to 25 °C for longer than 2 hours after
thawing.
FIBRINOGEN CALIBRATOR are supplied in siliconized vials in order to prevent contact activation of the
coagulation system.
FIBRINOGEN CALIBRATOR are adjusted to the following values:

fibrinogen concentration (approximately)

(g/L)
CALIBRATOR 1 0.6
CALIBRATOR 2 1.1
CALIBRATOR 3 2.5
CALIBRATOR 4 3.7
CALIBRATOR 5 6.0
CALIBRATOR 6 9.0
FIBRINOGEN CALIBRATOR are calibrated by determining the quantity of coagulable fibrinogen by the
method of Ratnoff and Menzie2 as well as by the Kjeldahl method. The exact values are given on the
enclosed lotdependent table of analytical values.
Warnings and Precautions
For in-vitro diagnostic use only.
For laboratory professional use.
Safety data sheets (MSDS/SDS) available on siemens-healthineers.com/sds.
CAUTION!
Federal (USA) law restricts this device to sale by or on the order of licensed healthcare professionals.

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CAUTION! POTENTIAL BIOHAZARD

CALIBRATOR 1 , CALIBRATOR 2 , CALIBRATOR 3 , CALIBRATOR 4 , CALIBRATOR 5 , CALIBRATOR 6
Each donor or donor unit was tested and found to be negative for human immunodeficiency virus
(HIV) 1 and 2, hepatitis B virus (HBV) and hepatitis C virus (HCV) using either tests that are CE marked
or FDA approved for this purpose. Because no known test can offer complete assurance of the
absence of infectious agents, all human derived products should be handled with appropriate
caution.
Dispose of hazardous or biologically contaminated materials according to the practices of your
institution. Discard all materials in a safe and acceptable manner and in compliance with all
government requirements.

Preparing Reagents
Reconstitute the Fibrinogen Calibrators with 1.0 mL of distilled water, shaking carefully to dissolve
(without foam formation). Allow to stand for at least 15 minutes at 15 to 25 °C.
Shake carefully before use.

Procedure
Materials Provided
REF Contents

OQVK11 Fibrinogen Calibrator Kit

FIBRINOGEN CALIBRATOR

Fibrinogen Calibrator, level 1 1× 1 mL

CALIBRATOR 1

Fibrinogen Calibrator, level 2 1× 1 mL

CALIBRATOR 2

Fibrinogen Calibrator, level 3 1× 1 mL

CALIBRATOR 3

Fibrinogen Calibrator, level 4 1× 1 mL

CALIBRATOR 4

Fibrinogen Calibrator, level 5 1× 1 mL

CALIBRATOR 5

Fibrinogen Calibrator, level 6 1× 1 mL

CALIBRATOR 6

Table of lot-specific Analytical Value

Materials Required but not Provided

Item Description
REF OWZG Multifibren® U
Coagulation analyzers, • BCS® XP System
such as: • BFT II Analyzer
• SYSMEX CA‑600 series
• SYSMEX CA-1500 System

Performing Calibration
The reference curve is prepared from duplicate or triplicate determinations of the FIBRINOGEN
CALIBRATOR coagulation times as instructed in the respective Instructions for Use. The mean values are
plotted on doublelogarithmic graph paper against the labelled fibrinogen concentration (see lot-
specific analytical table) and are then connected with a template to provide the reference curve.

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Internal Quality Control

The accuracy of the calibration curve should be assessed by running appropriate controls, which are
listed in each related reagent Instructions for Use.
If the controls exhibit systematic deviations from the declared confidence interval of the lot-dependent
Table of Assigned Values, a new reference curve must be established.

Limitations
The reference curve is valid for the relevant lot of the reagent used and must be renewed after a
change of lot as well as after any change in the experimental conditions.

Technical Assistance
For customer support, contact your local technical support provider or distributor.
siemens-healthineers.com

References
1. Clauss A. Gerinnungsphysiologische Schnellmethode zur Bestimmung des Fibrinogens. Acta
Haematol. 1957; 17: 237-46.
2. Ratnoff OD, Menzie C. A new method for the determination of fibrinogen in small samples of
plasma. J Lab Clin Med. 1951; 37: 316 - 20.

Definition of Symbols
The following symbols may appear on the product labeling:

Do not reuse Use By

LOT Batch Code REF Catalogue Number

Caution Manufacturer

Authorized representative in the

EC REP Contains sufficient for <n> tests
European Community
In Vitro Diagnostic Medical
Biological Risks IVD
Device

Temperature Limitation Consult instruction for Use

Non-sterile CE marking of conformity

CE marking of conformity with notified

body ID number. CONTENTS Contents
Notified body ID number can vary.

Reconstitution volume LEVEL Level

Keep away from sunlight and heat WARNING Warning

DANGER Danger RxOnly Prescription device (US only)

UDI Device Identification (UDI) barcode REACH xx/xx/xx REACH Authorization Number

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Legal Information
BCS and Multifibren are trademarks of Siemens Healthineers.
SYSMEX is a trademark of SYSMEX CORPORATION.
All other trademarks are the property of their respective owners.

© Siemens Healthineers, 2009–2021. All rights reserved.

Siemens Healthineers Headquarters Siemens Healthcare Diagnostics Products GmbH

Siemens Healthcare GmbH Emil-von-Behring-Str. 76
Henkestraße 127 35041 Marburg
91052 Erlangen Germany
Germany siemens-healthineers.com
Phone: +49 9131 84-0
siemens-healthineers.com

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