Cleared Traditional

K852848 - FDP ASSAY-20 TEST KIT

K852848 is the FDA 510(k) clearance for FDP ASSAY-20 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 97-day FDA review.

K852848 · American Bioproducts Co. · Hematology device
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Oct 1985
Decision
97d
Days
Class 2
Risk

K852848 is an FDA 510(k) clearance for the FDP ASSAY-20 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 October 10, 1985 after a review of 97 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

Submission Details

510(k) Number K852848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1985
Decision Date October 10, 1985
Days to Decision 97 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
16d faster than avg
Panel avg: 113d · This submission: 97d
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 19
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K852848.
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
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
K812298 · Syn-Kit, Inc. · Dec 1981