Cleared Traditional

K890788 - ADX COCAINE METABOLITE

K890788 is an FDA 510(k) clearance for ADX COCAINE METABOLITE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K890788 · Abbott Laboratories · Toxicology device
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Aug 1989
Decision
191d
Days
Class 2
Risk

K890788 is an FDA 510(k) clearance for the ADX COCAINE METABOLITE. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 191 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K890788

510(k) Number K890788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1989
Decision Date August 25, 1989
Days to Decision 191 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
104d slower than avg
Panel avg: 87d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIO Device Classification - Class 2, Special Controls

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 95
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K890788.
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · Syva Co. · Jul 1990
MICRO DAU COCAINE METABOLITE TEST KIT
K896781 · Immunotech Corp. · Mar 1990
HYCOR ACCUPINCH COCAINE TEST
K896937 · Hycor Biomedical, Inc. · Mar 1990
ABUSCREEN FP BUFFER REAGENT
K890883 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815 · Roche Diagnostic Systems, Inc. · Jul 1988