Cleared Traditional

K943283 - HEPARIN MANAGEMENT TEST CARD

Also marketed or referenced as:
HMT CARD

K943283 is the FDA 510(k) clearance for HEPARIN MANAGEMENT TEST CARD by Cardiovascular Diagnostics, Inc.. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K943283 · Cardiovascular Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
307d
Days
Class 2
Risk

K943283 is an FDA 510(k) clearance for the HEPARIN MANAGEMENT TEST CARD. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cardiovascular Diagnostics, Inc. devices

Submission Details

510(k) Number K943283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date May 10, 1995
Days to Decision 307 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
194d slower than avg
Panel avg: 113d · This submission: 307d
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 K943283.
ROTACHROM HBPM/LMWH TEST KIT
K943516 · American Bioproducts Co. · Aug 1995
THE STACHROM HEPARIN ASSAY KIT
K925433 · American Bioproducts Co. · May 1995
STACLOT HEPARIN TEST KIT
K943517 · American Bioproducts Co. · May 1995
HEMOLAB HEPARICHROM ASSAY
K934274 · Biomerieux Vitek, Inc. · May 1994
IL TEST HEPARIN (XA), PN 84699-15
K935212 · Instrumentation Laboratory CO · Feb 1994
BERICHROM HEPARIN
K925200 · Behring Diagnostics, Inc. · Jun 1993