Cleared Traditional

K935016 - COCAINE METABOLITE EIA ASSAY MODIFICATION

K935016 is the FDA 510(k) clearance for COCAINE METABOLITE EIA ASSAY MODIFICATION by Diagnostic Reagents, Inc.. It is a Class 2 Chemistry device (product code DIO) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K935016 · Diagnostic Reagents, Inc. · Chemistry device
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Dec 1993
Decision
46d
Days
Class 2
Risk

K935016 is an FDA 510(k) clearance for the COCAINE METABOLITE EIA ASSAY MODIFICATION. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3250 - the FDA in vitro diagnostics and chemistry 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 K935016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date December 03, 1993
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 Chemistry 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 K935016.
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS
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K933053 · Roche Diagnostic Systems, Inc. · Aug 1993
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K915371 · Diagnostic Reagents, Inc. · Dec 1991
SYVA EMIT D.A.U. COCAINE METABOLITE
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