Cleared Traditional

AMPHETAMINE/METHAMPHETAMINE (K012998) - FDA 510(k) Clearance

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

K012998 · Abbott Laboratories · Toxicology device
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Mar 2002
Decision
188d
Days
Class 2
Risk

K012998 is an FDA 510(k) clearance for the AMPHETAMINE/METHAMPHETAMINE. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 188 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 K012998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date March 13, 2002
Days to Decision 188 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 87d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 12
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K012998.
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K153693 · Immunalysis Corporation · Mar 2016
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
K150096 · Healgen Scientific, LLC · Mar 2015
ROCHE FLUDI METHAMPHETAMINE
K093884 · Roche Diagnostics · Feb 2011
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · Roche Diagnostics Corp. · Apr 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · Syva Co. · Jan 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634 · Diagnostic Products Corp. · Jan 2000