Cleared Traditional

K896781 - MICRO DAU COCAINE METABOLITE TEST KIT

K896781 is the FDA 510(k) clearance for MICRO DAU COCAINE METABOLITE TEST KIT by Immunotech Corp.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K896781 · Immunotech Corp. · Toxicology device
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Mar 1990
Decision
109d
Days
Class 2
Risk

K896781 is an FDA 510(k) clearance for the MICRO DAU COCAINE METABOLITE TEST KIT. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunotech Corp. devices

Submission Details

510(k) Number K896781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date March 23, 1990
Days to Decision 109 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 slower than avg
Panel avg: 87d · This submission: 109d
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 K896781.
COCAINE METABOLITE EIA TEST
K915371 · Diagnostic Reagents, Inc. · Dec 1991
SYVA EMIT D.A.U. COCAINE METABOLITE
K914973 · Syva Co. · Nov 1991
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · Syva Co. · Jul 1990
HYCOR ACCUPINCH COCAINE TEST
K896937 · Hycor Biomedical, Inc. · Mar 1990
ADX COCAINE METABOLITE
K890788 · Abbott Laboratories · Aug 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · Roche Diagnostic Systems, Inc. · Mar 1989