Cleared Traditional

K890399 - MODIFIED D-DI-TEST KIT

K890399 is the FDA 510(k) clearance for MODIFIED D-DI-TEST KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GHH) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K890399 · American Bioproducts Co. · Hematology device
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Feb 1989
Decision
14d
Days
Class 2
Risk

K890399 is an FDA 510(k) clearance for the MODIFIED D-DI-TEST KIT. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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 American Bioproducts Co. devices

Submission Details

510(k) Number K890399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date February 07, 1989
Days to Decision 14 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
99d faster than avg
Panel avg: 113d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHH Fibrin Split Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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 - GHH Fibrin Split Products

All 18
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K890399.
FDP - SLIDEX DIRECT
K921989 · Biomerieux Vitek, Inc. · Nov 1993
ABBOTT IMX(TM) D-DIMER
K893961 · Abbott Laboratories · Aug 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · Abbott Laboratories · Mar 1989
FIBRINOSTICON
K880077 · Organon Teknika Corp. · Feb 1988
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360 · American Dade · Jul 1987
D-DI TEST KIT
K861973 · American Bioproducts Co. · Sep 1986