Cleared Traditional

K924638 - HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-...

K924638 is the FDA 510(k) clearance for HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-... by International Technidyne Corp.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K924638 · International Technidyne Corp. · Hematology device
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Jan 1993
Decision
135d
Days
Class 2
Risk

K924638 is an FDA 510(k) clearance for the HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on January 14, 1993 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 International Technidyne Corp. devices

Submission Details

510(k) Number K924638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date January 14, 1993
Days to Decision 135 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
22d slower than avg
Panel avg: 113d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 20
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K924638.
SYNTHASIL APTT REAGENT
K953981 · Ortho Diagnostic Systems, Inc. · Nov 1995
APTT-ES
K935169 · Helena Laboratories · Dec 1994
PATHROMTIN
K932011 · Behring Diagnostics, Inc. · Oct 1993
STACLOT LA TEST KIT
K923731 · American Bioproducts Co. · Dec 1992
PLATELIN L
K921396 · Organon Teknika Corp. · Oct 1992
ELLAGIC ACID APTT REAGENT
K915418 · Helena Laboratories · Feb 1992