Cleared Traditional

K915083 - COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915083 · Kabi Pharmacia, Inc. · Hematology device
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Jan 1992
Decision
52d
Days
Class 2
Risk

K915083 is an FDA 510(k) clearance for the COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Kabi Pharmacia, Inc. (Franklin, US). The FDA issued a Cleared decision on January 3, 1992 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - 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 Kabi Pharmacia, Inc. devices

Submission Details

510(k) Number K915083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1991
Decision Date January 03, 1992
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 113d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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.