Cleared Traditional

K890788 - ADX COCAINE METABOLITE (FDA 510(k) Clearance)

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

K890788 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 144
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K890788.
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
K213211 · Carolina Liquid Chemistries Corp. · Jan 2022
DRI Cocaine Metabolite Assay
K211973 · Microgenics Corporation · Sep 2021
DRI Cocaine Metabolite Assay
K181499 · Microgenics Corporation · Jul 2018
Emit II Plus Cocaine Metabolite Assay
K170293 · Siemens Healthcare Diagnostics, Inc. · Oct 2017
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
K161214 · Guangzhou Wondfo Biotech Co., Ltd. · Jun 2016
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
K150925 · Immunalysis Corporation · Jun 2015