Cleared Traditional

K943283 - HEPARIN MANAGEMENT TEST CARD

Also marketed or referenced as:
HMT CARD

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

K943283 · Cardiovascular Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K943283

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.

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 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