Cleared Traditional

K902393 - COACUTE ANTITHROMBIN CHROMOGENIC ASSAY

K902393 is an FDA 510(k) clearance for COACUTE ANTITHROMBIN CHROMOGENIC ASSAY, manufactured by Kabi Diagnostica. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K902393 · Kabi Diagnostica · Hematology device
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Sep 1990
Decision
118d
Days
Class 2
Risk

K902393 is an FDA 510(k) clearance for the COACUTE ANTITHROMBIN CHROMOGENIC ASSAY. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Kabi Diagnostica (Danville, US). The FDA issued a Cleared decision on September 25, 1990 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kabi Diagnostica devices

FDA 510(k) Submission Details - K902393

510(k) Number K902393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date September 25, 1990
Days to Decision 118 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 113d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBQ Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K902393.
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
ACTICHROME ATIII KIT
K893608 · American Diagnostic Corp. · Jun 1989