Cleared Traditional

K010193 - HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

K010193 is an FDA 510(k) clearance for HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND ..., manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K010193 · International Technidyne Corp. · Hematology device
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Jun 2001
Decision
135d
Days
Class 2
Risk

K010193 is an FDA 510(k) clearance for the HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on June 6, 2001 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 864.7525 - 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

FDA 510(k) Submission Details - K010193

510(k) Number K010193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2001
Decision Date June 06, 2001
Days to Decision 135 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
22d slower than avg
Panel avg: 113d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFF Device Classification - Class 2, Special Controls

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 30
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K010193.
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STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
K111822 · Diagnostica Stago, Inc. · Oct 2011
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209 · Instrumentation Laboratory CO · Jun 2009
COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998
IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998
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K972209 · Medical Diagnostic Technologies, Inc. · Aug 1997