Cleared Traditional

LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II (K895210) - FDA 510(k) Clearance

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

K895210 · Abbott Laboratories · Toxicology device
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Sep 1989
Decision
38d
Days
Class 2
Risk

K895210 is an FDA 510(k) clearance for the LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II. 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 September 25, 1989 after a review of 38 days - a notably fast clearance 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: 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 K895210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1989
Decision Date September 25, 1989
Days to Decision 38 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
49d faster than avg
Panel avg: 87d · This submission: 38d
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 K895210.
MILENIA (TM) AMPHETAMINE
K902979 · Diagnostic Products Corp. · Sep 1990
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
K900995 · Syva Co. · Apr 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · Roche Diagnostic Systems, Inc. · Mar 1990
ADX AMPHETAMINE/METHAMPHEAMINE
K890692 · Abbott Laboratories · Aug 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465 · Roche Diagnostic Systems, Inc. · Aug 1989
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K894404 · Syva Co. · Aug 1989