Cleared Traditional

K965076 - MDA HEPARIN ANTI-X ASSAY

K965076 is an FDA 510(k) clearance for MDA HEPARIN ANTI-X ASSAY, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K965076 · Organon Teknika Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
89d
Days
Class 2
Risk

K965076 is an FDA 510(k) clearance for the MDA HEPARIN ANTI-X ASSAY. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K965076

510(k) Number K965076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date March 18, 1997
Days to Decision 89 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
24d faster than avg
Panel avg: 113d · This submission: 89d
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 29
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K965076.
COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998
IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · Medical Diagnostic Technologies, Inc. · Aug 1997
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996
THE HEPANORM HBPM/LMWH KIT
K943514 · American Bioproducts Co. · Sep 1995
HBPM/LMWH CONTROL KIT
K943519 · American Bioproducts Co. · Sep 1995