HEMOSIL FIBRINOGEN-C

K073367 · Instrumentation Laboratory CO · KQJ · Dec 27, 2007 · Hematology

Device Facts

• Record ID: K073367
• Device Name: HEMOSIL FIBRINOGEN-C
• Applicant: Instrumentation Laboratory CO
• Product Code: KQJ · Hematology
• Decision Date: Dec 27, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Indications for Use

HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems. For in vitro diagnostic use.

Device Story

HemosIL Fibrinogen-C reagent modification for use on ACL TOP instrument; optimizes test parameters including reflex testing, direct dilution, and incubation time; expands linearity and interference claims; intended for clinical laboratory use to measure fibrinogen levels; provides quantitative results to healthcare providers for coagulation assessment.

Clinical Evidence

Bench testing only. Performance data compared current and modified parameters on the ACL TOP system. Linearity was expanded from 80-700 mg/dL to 35-1000 mg/dL. Precision studies showed improved within-run CVs (Normal: 4.5% vs 7.9%; Low: 5.1% vs 7.7%). Interference testing confirmed performance for Heparin, Hemoglobin, and Bilirubin; FDP interference was identified and addressed via labeling updates.

Technological Characteristics

In vitro diagnostic reagent kit; Clauss method (thrombin-based coagulation assay). Designed for use on IL Coagulation Systems (ACL TOP). Optimized math model and incubation parameters. Linearity range: 35-1000 mg/dL.

Indications for Use

Indicated for quantitative determination of fibrinogen in human citrated plasma using the Clauss method on IL Coagulation Systems for in vitro diagnostic use.

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

• HemosIL Fibrinogen-C (K931721)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K073367

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: HemosIL Fibrinogen-C, K931721
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use.
3. A description of the device MODIFICATION(S), including user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for: To expand the linearity claims, the test parameters for the HemosIL Fibrinogen-C on the ACL TOP (K063679) are being optimized. The test parameter optimization (reflex testing, direct dilution, and incubation time) results in new linearity and interference claims impacting the instrument specific performance claims in the reagent package insert.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, test principle, parameter optimizations, associated math model optimization, precision, and linearity. Performance characteristics, including method comparison, expected value range verification, linearity, and interference studies, are met as described in the analytical validation protocol.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Revised: 8/1/03
(Reviewer's Signature)
(Date)