Cleared Traditional

K972866 - HEMOCHRON JR. MIOCROCOAGULATION CITRATE...

K972866 is the FDA 510(k) clearance for HEMOCHRON JR. MIOCROCOAGULATION CITRATE... by International Technidyne Corp.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K972866 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
422d
Days
Class 2
Risk

K972866 is an FDA 510(k) clearance for the HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all International Technidyne Corp. devices

Submission Details

510(k) Number K972866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1997
Decision Date September 30, 1998
Days to Decision 422 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 113d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 76
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K972866.
HEMOSIL RECOMBI PLASTIN
K012768 · Instrumentation Laboratory CO · Sep 2001
THROMBOREL S
K003870 · Dade Behring, Inc. · Feb 2001
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
K992492 · Roche Diagnostics Corp. · Nov 1999
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · Instrumentation Laboratory CO · Jul 1998
MDA SIMPLASTIN HTF
K974566 · Organon Teknika Corp. · Feb 1998
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · Sigma Diagnostics, Inc. · Oct 1997