Cleared Traditional

K890692 - ADX AMPHETAMINE/METHAMPHEAMINE

K890692 is an FDA 510(k) clearance for ADX AMPHETAMINE/METHAMPHEAMINE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

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.

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FDA 510(k) Submission Details - K890692

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.

DKZ Device Classification - Class 2, Special Controls

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 140
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