Cleared Special

HemosIL Fibrinogen-C (K251968) - FDA 510(k) Clearance

Also marketed or referenced as:
HemosIL Fibrinogen-C XL

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251968 · Instrumentation Laboratory (IL) Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
28d
Days
Class 2
Risk

K251968 is an FDA 510(k) clearance for the HemosIL Fibrinogen-C. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on July 24, 2025 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Instrumentation Laboratory (IL) Co. devices

Submission Details

510(k) Number K251968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2025
Decision Date July 24, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KQJ System, Fibrinogen Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KQJ System, Fibrinogen Determination

All 27
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K251968.
HEMOSIL FIBRINOGEN-C
K073367 · Instrumentation Laboratory CO · Dec 2007
DADE THROMBIN REAGENT
K050928 · Dade Behring, Inc. · Jun 2005
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
QBC FIBRINOGEN
K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1992
FIBRINOGEN ASSAY KIT
K841020 · Helena Laboratories · May 1984
ACA FIBRINOGEN TEST PACK
K812629 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981