Cleared Traditional

FIBRINOTEST(TM) - FIBRINOGEN ASSAY (K903874) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903874 · Haemachem, Inc. · Hematology device
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Feb 1991
Decision
176d
Days
Class 2
Risk

K903874 is an FDA 510(k) clearance for the FIBRINOTEST(TM) - FIBRINOGEN ASSAY. Classified as Test, Fibrinogen (product code GIS), Class II - Special Controls.

Submitted by Haemachem, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 14, 1991 after a review of 176 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 Haemachem, Inc. devices

Submission Details

510(k) Number K903874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1990
Decision Date February 14, 1991
Days to Decision 176 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 113d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.