Cleared Traditional

K972209 - SPECTROLYSE HEPARIN (ANTI-IIA)

K972209 is an FDA 510(k) clearance for SPECTROLYSE HEPARIN (ANTI-IIA), manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K972209 · Medical Diagnostic Technologies, Inc. · Hematology device
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Aug 1997
Decision
62d
Days
Class 2
Risk

K972209 is an FDA 510(k) clearance for the SPECTROLYSE HEPARIN (ANTI-IIA). Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 62 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 Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K972209

510(k) Number K972209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1997
Decision Date August 12, 1997
Days to Decision 62 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 113d · This submission: 62d
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 K972209.
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · International Technidyne Corp. · Jun 2001
COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998
IL TEST HEPARIN
K980242 · Instrumentation Laboratory CO · Mar 1998
MDA HEPARIN ANTI-X ASSAY
K965076 · Organon Teknika Corp. · Mar 1997
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996
THE HEPANORM HBPM/LMWH KIT
K943514 · American Bioproducts Co. · Sep 1995