Cleared Traditional

K923921 - IL TEST PT FIBRINOGEN HS

K923921 is an FDA 510(k) clearance for IL TEST PT FIBRINOGEN HS, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GIS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K923921 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
82d
Days
Class 2
Risk

K923921 is an FDA 510(k) clearance for the IL TEST PT FIBRINOGEN HS. Classified as Test, Fibrinogen (product code GIS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K923921

510(k) Number K923921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date October 26, 1992
Days to Decision 82 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
31d faster than avg
Panel avg: 113d · This submission: 82d
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 8
Devices cleared under the same product code (GIS) and FDA review panel - the closest regulatory comparables to K923921.
K-ASSAY FIBRINOGEN
K993482 · Kamiya Biomedical Co. · Dec 1999
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · Ortho Diagnostic Systems, Inc. · Nov 1996
BIOMERIEUX HEMOLAB FIBRINOMAT
K925494 · Biomerieux Vitek, Inc. · May 1993
FIBRINOGEN DETERMINATION KIT
K913061 · Sigma Diagnostics, Inc. · Oct 1991
FIBRINOGENTEST-O
K881685 · Diatech, Inc. · Aug 1988
KINETIC FIBRINOGEN ASSAY
K881150 · Bio/Data Corp. · Mar 1988