Cleared Traditional

ADX AMPHETAMINE/METHAMPHEAMINE (K890692) - FDA 510(k) Clearance

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

K890692 · Abbott Laboratories · Toxicology device
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Aug 1989
Decision
196d
Days
Class 2
Risk

K890692 is an FDA 510(k) clearance for the ADX AMPHETAMINE/METHAMPHEAMINE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), 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 196 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 K890692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1989
Decision Date August 25, 1989
Days to Decision 196 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
109d slower than avg
Panel avg: 87d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 77
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K890692.
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
K900995 · Syva Co. · Apr 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · Roche Diagnostic Systems, Inc. · Mar 1990
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · Abbott Laboratories · Sep 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465 · Roche Diagnostic Systems, Inc. · Aug 1989
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K894404 · Syva Co. · Aug 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886 · Roche Diagnostic Systems, Inc. · Mar 1989