Cleared Traditional

K871305 - COCAINE METABOLITE ENZYME IMMUNOASSAY KIT

K871305 is the FDA 510(k) clearance for COCAINE METABOLITE ENZYME IMMUNOASSAY KIT by General Diagnostics. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K871305 · General Diagnostics · Toxicology device
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Jun 1987
Decision
65d
Days
Class 2
Risk

K871305 is an FDA 510(k) clearance for the COCAINE METABOLITE ENZYME IMMUNOASSAY KIT. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by General Diagnostics (Great Neck, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 65 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.

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Submission Details

510(k) Number K871305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1987
Decision Date June 05, 1987
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
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 K871305.
REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY
K874201 · Syva Co. · Oct 1987
LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE
K873751 · Diagnostic Products Corp. · Oct 1987
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY
K873752 · Diagnostic Products Corp. · Oct 1987
COCAINE METABOLITE ROCHE(R) EIA
K863843 · Roche Diagnostic Systems, Inc. · Mar 1987
TDX COCAINE METABOLITE
K854163 · Abbott Laboratories · Nov 1985
EMIT D.A.U. COCAINE ASSAY
K843556 · Syva Co. · Oct 1984