Cleared Traditional

K960187 - COCAINE METABOLITE EIA TEST

K960187 is the FDA 510(k) clearance for COCAINE METABOLITE EIA TEST by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K960187 · Diagnostic Reagents, Inc. · Toxicology device
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Apr 1996
Decision
77d
Days
Class 2
Risk

K960187 is an FDA 510(k) clearance for the COCAINE METABOLITE EIA TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 2, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K960187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date April 02, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 Toxicology devices follow this clearance model.

Regulatory Peers - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 82
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K960187.
ONTRAK TESTCUP-ER
K983388 · Roche Diagnostic Systems, Inc. · Nov 1998
IMMULITE COCAINE METABOLITE
K963918 · Diagnostic Products Corp. · Apr 1997
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
K962353 · Princeton BioMeditech Corp. · Aug 1996
FRONTLINE COCAINE
K954496 · Boehringer Mannheim Corp. · Mar 1996
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
K954571 · Princeton BioMeditech Corp. · Nov 1995
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET
K945549 · Princeton BioMeditech Corp. · Oct 1995