Cleared Traditional

K900396 - ORTHOKROME* HEPARIN

K900396 is an FDA 510(k) clearance for ORTHOKROME* HEPARIN, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code KFF cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K900396 · Ortho Diagnostic Systems, Inc. · Hematology device
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Mar 1990
Decision
45d
Days
Class 2
Risk

K900396 is an FDA 510(k) clearance for the ORTHOKROME* HEPARIN. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on March 15, 1990 after a review of 45 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.

FDA 510(k) Submission Details - K900396

510(k) Number K900396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date March 15, 1990
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 113d · This submission: 45d
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 46
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K900396.
HEMOCHRON(R) HEPARIN RESPONSE TEST
K904003 · Intensive Technology, Inc. · Nov 1990
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · Organon Teknika Corp. · Oct 1990
COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
K901874 · Kabi Diagnostica · Jul 1990
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
K884590 · Hemotec, Inc. · Jan 1989
IL TEST 97575-15, HEPARIN ASSAY
K864211 · Instrumentation Laboratory CO · Jan 1987
HEPANORM CALIBRATION PLASMA SET
K854762 · American Bioproducts Co. · Mar 1986
K900396 · ORTHOKROME* HEPARIN
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