Cleared Traditional

K915371 - COCAINE METABOLITE EIA TEST

K915371 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 21-day FDA review.

K915371 · Diagnostic Reagents, Inc. · Toxicology device
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Dec 1991
Decision
21d
Days
Class 2
Risk

K915371 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. (Santa Clara, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 21 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 K915371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date December 18, 1991
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
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 K915371.
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K933053 · Roche Diagnostic Systems, Inc. · Aug 1993
SYVA EMIT D.A.U. COCAINE METABOLITE
K914973 · Syva Co. · Nov 1991
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · Syva Co. · Jul 1990
MICRO DAU COCAINE METABOLITE TEST KIT
K896781 · Immunotech Corp. · Mar 1990