Cleared Traditional

REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA. (K880013) - FDA 510(k) Clearance

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

K880013 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
57d
Days
Class 2
Risk

K880013 is an FDA 510(k) clearance for the REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.. 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 March 1, 1988 after a review of 57 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 K880013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1988
Decision Date March 01, 1988
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
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 K880013.
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K884022 · Syva Co. · Oct 1988
EMIT HVA AMPHETAMINE ASSAY
K882589 · Syva Co. · Aug 1988
TDX (R) AMPHETAMINE CLASS
K874770 · Abbott Laboratories · Apr 1988
ABUSCREEN(R) EIA AMPHETAMINE
K874836 · Roche Diagnostic Systems, Inc. · Feb 1988
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
K874486 · Abbott Laboratories · Nov 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874273 · Roche Diagnostic Systems, Inc. · Nov 1987