Cleared Traditional

K925494 - BIOMERIEUX HEMOLAB FIBRINOMAT

K925494 is an FDA 510(k) clearance for BIOMERIEUX HEMOLAB FIBRINOMAT, manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Hematology device with product code GIS cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K925494 · Biomerieux Vitek, Inc. · Hematology device
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May 1993
Decision
197d
Days
Class 2
Risk

K925494 is an FDA 510(k) clearance for the BIOMERIEUX HEMOLAB FIBRINOMAT. Classified as Test, Fibrinogen (product code GIS), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 18, 1993 after a review of 197 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

FDA 510(k) Submission Details - K925494

510(k) Number K925494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date May 18, 1993
Days to Decision 197 days
Submission Type Traditional
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
84d slower than avg
Panel avg: 113d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIS Device Classification - Class 2, Special Controls

Product Code GIS Test, Fibrinogen
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 - GIS Test, Fibrinogen

All 9
Devices cleared under the same product code (GIS) and FDA review panel - the closest regulatory comparables to K925494.
FIBROTEK FIB
K042919 · R2 Diagnostics, Inc. · Nov 2004
K-ASSAY FIBRINOGEN
K993482 · Kamiya Biomedical Co. · Dec 1999
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · Ortho Diagnostic Systems, Inc. · Nov 1996
IL TEST PT FIBRINOGEN HS
K923921 · Instrumentation Laboratory CO · Oct 1992
FIBRINOGEN DETERMINATION KIT
K913061 · Sigma Diagnostics, Inc. · Oct 1991
FIBRINOGENTEST-O
K881685 · Diatech, Inc. · Aug 1988