Cleared Traditional

K915083 - COAMATE ANTITHROMBIN CHROMOGENIC ASSAY

K915083 is the FDA 510(k) clearance for COAMATE ANTITHROMBIN CHROMOGENIC ASSAY by Kabi Pharmacia, Inc.. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K915083 · Kabi Pharmacia, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 40
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K915083.
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308 · Sigma Diagnostics, Inc. · May 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · Baxter Diagnostics, Inc. · May 1994
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
K913667 · The Binding Site, Ltd. · Jan 1992
LIATEST(R) AT III TEST KIT
K905110 · American Bioproducts Co. · Jan 1991
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977 · Beckman Instruments, Inc. · Aug 1990
ORTHOKROME* ANTITHROMBIN
K900400 · Ortho Diagnostic Systems, Inc. · Mar 1990