Cleared Traditional

K904003 - HEMOCHRON HEPARIN RESPONSE TEST

K904003 is the FDA 510(k) clearance for HEMOCHRON HEPARIN RESPONSE TEST by Intensive Technology, Inc.. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 29
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