HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

K251968 · Instrumentation Laboratory (IL) Co. · KQJ · Jul 24, 2025 · Hematology

Device Facts

• Record ID: K251968
• Device Name: HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
• Applicant: Instrumentation Laboratory (IL) Co.
• Product Code: KQJ · Hematology
• Decision Date: Jul 24, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Indications for Use

The HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL are intended for the quantitative determination of fibrinogen in human citrated plasma on ACL systems.

Device Story

HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL are in vitro diagnostic reagents used for quantitative fibrinogen measurement in human citrated plasma; utilized on ACL systems in clinical laboratory settings; modification involves updated storage specifications for reconstituted bovine thrombin reagent; fundamental scientific technology remains unchanged; device provides fibrinogen concentration data to assist clinicians in assessing coagulation status.

Clinical Evidence

No clinical data; bench testing and design control activities performed to verify the impact of modified storage specifications for the reconstituted reagent.

Technological Characteristics

Lyophilized bovine thrombin (35 UNIH/mL) with bovine albumin, calcium chloride, buffer, and stabilizers. Operates on IL Coagulation Systems (ACL Elite, ACL TOP families). Quantitative assay based on the Clauss method.

Indications for Use

Indicated for the quantitative determination of fibrinogen in human citrated plasma for patients requiring evaluation of fibrinogen levels, including those with congenital fibrinogen abnormalities, disseminated intravascular coagulation, liver disease, inflammatory diseases, malignancy, or those undergoing thrombolytic therapy.

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; HemosIL Fibrinogen-C XL (K251968 - original clearance)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K251968

B Applicant

Instrumentation Laboratory (IL) Co.

C Proprietary and Established Names

HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| KQJ | Class II | 21 CFR 864.7340 - Fibrinogen Determination System | HE - Hematology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, 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 is for modified storage specifications for the reconstituted form of the Bovine thrombin reagent, in the device labeling.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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.

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.

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