Cleared Traditional

K872360 - DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(...

K872360 is the FDA 510(k) clearance for DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(... by American Dade. It is a Class 2 Hematology device (product code GHH) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K872360 · American Dade · Hematology device
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Jul 1987
Decision
18d
Days
Class 2
Risk

K872360 is an FDA 510(k) clearance for the DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 6, 1987 after a review of 18 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 Dade devices

Submission Details

510(k) Number K872360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1987
Decision Date July 06, 1987
Days to Decision 18 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
95d faster than avg
Panel avg: 113d · This submission: 18d
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 K872360.
ABBOTT TESTPACK(TM) D-DIMER
K890422 · Abbott Laboratories · Mar 1989
MODIFIED D-DI-TEST KIT
K890399 · American Bioproducts Co. · Feb 1989
FIBRINOSTICON
K880077 · Organon Teknika Corp. · Feb 1988
D-DI TEST KIT
K861973 · American Bioproducts Co. · Sep 1986
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