FIBRINOGEN CALIBRATOR KIT

K072304 · Dade Behring, Inc. · GFX · Sep 19, 2007 · Hematology

Device Facts

• Record ID: K072304
• Device Name: FIBRINOGEN CALIBRATOR KIT
• Applicant: Dade Behring, Inc.
• Product Code: GFX · Hematology
• Decision Date: Sep 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Indications for Use

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.

Device Story

Fibrinogen Calibrator Kit consists of six lyophilized calibrators derived from pooled human plasma; donors selected for health; plasma diluted with buffer or supplemented with purified fibrinogen; stabilized with Herpes Buffer. Supplied in siliconized vials to prevent coagulation contact activation. Used in clinical laboratory settings to establish reference curves for fibrinogen assays performed on automated coagulation analyzers (e.g., Dade Behring BCS, Sysmex CA-1500). Calibrator values assigned via Ratnoff and Menzie method and Kjeldahl method. Healthcare providers use these reference curves to quantify fibrinogen levels in patient samples, aiding in the assessment of coagulation status.

Clinical Evidence

No clinical data. Bench testing only. Evaluation of the new value assignment procedure involved testing three lots of the calibrator kit with two lots of Multifibren™ U reagent on Dade Behring BCS and Sysmex® CA-1500 analyzers. Results demonstrated that patient samples and quality control materials recovered fibrinogen values within expected ranges.

Technological Characteristics

Lyophilized pooled human plasma; stabilized with Herpes Buffer (12g/L); supplied in siliconized vials. Quantitative calibrator for fibrinogen assay. No specific software or electronic connectivity; used as a reagent component in coagulation analyzers.

Indications for Use

Indicated for use in preparing reference curves for the quantitative assay of fibrinogen via the Clauss method using Dade Behring Multifibren™ U reagent.

Regulatory Classification

Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Fibrinogen Calibrator Kit (K994341)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K072304

B. Purpose for Submission:
Change in value assignment procedure

C. Measurand:
Fibrinogen

D. Type of Test:
Quantitative

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Fibrinogen Calibrator Kit

G. Regulatory Information:
1. Regulation section:
21 CFR 864.7340, Fibrinogen determination system
2. Classification:
Class II
3. Product code:
GFX, Fibrinogen Standard
4. Panel:
Hematology (81)

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H. Intended Use:

1. Intended use(s):

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.

2. Indication(s) for use:

Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.

3. Special conditions for use statement(s):

Not applicable.

4. Special instrument requirements:

Not applicable.

I. Device Description:

The Fibrinogen Calibrators are lyophilized calibrators prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized. This calibrator is supplied in a one pack, containing 6 - 1.0 mL vials.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Fibrinogen Calibrator Kit

2. Predicate K number(s):

K994341

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Fibrinogen Calibrator Kit | Fibrinogen Calibrator Kit K994341 |
| Intended Use | Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U. | Same |
| Matrix | Pooled human plasma from healthy donors diluted with buffer solution or supplemented with purified fibrinogen. | Same |
| Analyte | Fibrinogen | Same |
| Target concentrations | 1 – 0.6 g/L
2 – 1.1 g/L
3 – 2.5 g/L
4 – 3.7 g/L
5 – 6.0 g/L
6 – 9.0 g/L | Same |
| Form | Lyophilized | Same |

K. Standard/Guidance Document Referenced (if applicable):

Not Applicable.

L. Test Principle:

The Fibrinogen Calibrators consists of pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and are stabilized with Herpes Buffer (12g/L) and lyophilized. They are supplied in siliconized vials in order to prevent contact activation of the coagulation system. These calibrators are assigned by determining the quality of coagulable fibrinogen by the method of Ratnoff and Menzie as well as by the Kjeldahl method. The exact values are given on the enclosed lot-dependant table of analytical values and on the vial labels.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable.
b. Linearity/assay reportable range:
Not Applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The new value assignment procedure was evaluated by testing three (3) lots of the Fibrinogen Calibrator Kit with two (2) lots of Multifibren™ U reagent on a Dade Behring BCS and a Sysmex® CA-1500 analyzer. Patient samples spanning the measuring range and quality control materials recovered fibrinogen values within the expected ranges.
d. Detection limit:
Not Applicable.
e. Analytical specificity:
Not Applicable.
f. Assay cut-off:
Not Applicable.

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable.
b. Matrix comparison:
Not Applicable.

3. Clinical studies:
a. Clinical Sensitivity:

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Not Applicable.

b. Clinical specificity:

Not Applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

Not Applicable.

4. Clinical cut-off:

Not Applicable.

5. Expected values/Reference range:

The exact values are given on an enclosed lot-dependant table of analytical values and on the vial labels. The calibrators are adjusted to the following values:

1 – 0.6 g/L
2 – 1.1 g/L
3 – 2.5 g/L
4 – 3.7 g/L
5 – 6.0 g/L
6 – 9.0 g/L

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.