Cleared Traditional

K904003 - HEMOCHRON(R) HEPARIN RESPONSE TEST

K904003 is an FDA 510(k) clearance for HEMOCHRON HEPARIN RESPONSE TEST, manufactured by Intensive Technology, Inc.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K904003 · Intensive Technology, Inc. · Hematology device
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Nov 1990
Decision
92d
Days
Class 2
Risk

K904003 is an FDA 510(k) clearance for the HEMOCHRON(R) HEPARIN RESPONSE TEST. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Intensive Technology, Inc. (Edison, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 92 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 Intensive Technology, Inc. devices

FDA 510(k) Submission Details - K904003

510(k) Number K904003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date November 29, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
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 33
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K904003.
BERICHROM HEPARIN
K925200 · Behring Diagnostics, Inc. · Jun 1993
HITT BY HEMOCHRON(R)
K910181 · International Technidyne Corp. · May 1991
HEPARIN CONTROLS, HIGH AND LOW
K910741 · Sigma Diagnostics, Inc. · Apr 1991
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · Organon Teknika Corp. · Oct 1990
ORTHOKROME* HEPARIN
K900396 · Ortho Diagnostic Systems, Inc. · Mar 1990
IL TEST 97575-15, HEPARIN ASSAY
K864211 · Instrumentation Laboratory CO · Jan 1987