Cleared Traditional

K972831 - HEMOCHRON CITRATE APTT

K972831 is the FDA 510(k) clearance for HEMOCHRON CITRATE APTT by International Technidyne Corp.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K972831 · International Technidyne Corp. · Hematology device
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Nov 1997
Decision
113d
Days
Class 2
Risk

K972831 is an FDA 510(k) clearance for the HEMOCHRON CITRATE 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 November 20, 1997 after a review of 113 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 K972831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1997
Decision Date November 20, 1997
Days to Decision 113 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
At panel average
Panel avg: 113d · This submission: 113d
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 K972831.
HEMOSIL SILICA CLOTTING TIME
K050221 · Instrumentation Laboratory CO · Mar 2005
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · Sigma Diagnostics, Inc. · Dec 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · Sigma Diagnostics, Inc. · Dec 1999
IL TEST APTT-SP
K973306 · Instrumentation Laboratory CO · Nov 1997
SYNTHAFAX APTT REAGENT
K955638 · Ortho Diagnostic Systems, Inc. · Apr 1996
PATHROMTIN SL
K955450 · Behring Diagnostics, Inc. · Apr 1996