Cleared Traditional

K923593 - HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AN...

K923593 is the FDA 510(k) clearance for HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AN... by International Technidyne Corp.. It is a Class 2 Hematology device (product code KQJ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K923593 · International Technidyne Corp. · Hematology device
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Sep 1992
Decision
64d
Days
Class 2
Risk

K923593 is an FDA 510(k) clearance for the HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 64 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 International Technidyne Corp. devices

Submission Details

510(k) Number K923593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date September 22, 1992
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 17
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K923593.
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
FIBRINOGEN RID TEST KIT
K922416 · The Binding Site, Ltd. · Mar 1993
MULTIFIBREN
K925988 · Behring Diagnostics, Inc. · Mar 1993
QBC FIBRINOGEN
K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1992
COAG-A-MATE - RA4
K900895 · Organon Teknika Corp. · Apr 1990
TURBOX FIBRINOGEN
K884179 · Unipath , Ltd. · Dec 1988