Cleared Traditional

K861973 - D-DI TEST KIT

K861973 is an FDA 510(k) clearance for D-DI TEST KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GHH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K861973 · American Bioproducts Co. · Hematology device
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Sep 1986
Decision
106d
Days
Class 2
Risk

K861973 is an FDA 510(k) clearance for the 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 September 4, 1986 after a review of 106 days - within the typical 510(k) review window.

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: 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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K861973

510(k) Number K861973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1986
Decision Date September 04, 1986
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GHH Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K861973.
MODIFIED D-DI-TEST KIT
K890399 · American Bioproducts Co. · Feb 1989
FIBRINOSTICON
K880077 · Organon Teknika Corp. · Feb 1988
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360 · American Dade · Jul 1987
FDP ASSAY-20 TEST KIT
K852848 · American Bioproducts Co. · Oct 1985
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1985
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K852512 · Pacific Hemostasis · Sep 1985