Cleared Traditional

REVISED LABELING FOR ADX COCAINE METABOLITE (K880009) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880009 · Abbott Laboratories · Toxicology device
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Mar 1988
Decision
67d
Days
Class 2
Risk

K880009 is an FDA 510(k) clearance for the REVISED LABELING FOR 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 March 11, 1988 after a review of 67 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 Abbott Laboratories devices

Submission Details

510(k) Number K880009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1988
Decision Date March 11, 1988
Days to Decision 67 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
20d faster than avg
Panel avg: 87d · This submission: 67d
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 46
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K880009.
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
EMIT HVA COCAINE METABOLITE ASSAY
K881942 · Syva Co. · Jul 1988
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · Abbott Laboratories · Nov 1987
ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN
K874213 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1987
REVISED LABELING FOR COCAINE/COCAINE META. TEST
K874271 · Roche Diagnostic Systems, Inc. · Nov 1987