Cleared Traditional

K033299 - ACON MAMP ONE STEP METHAMPHETAMINE TEST...

K033299 is the FDA 510(k) clearance for ACON MAMP ONE STEP METHAMPHETAMINE TEST... by ACON Laboratories, Inc.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K033299 · ACON Laboratories, Inc. · Toxicology device
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Dec 2003
Decision
59d
Days
Class 2
Risk

K033299 is an FDA 510(k) clearance for the ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on December 12, 2003 after a review of 59 days - a notably fast clearance 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: 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K033299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date December 12, 2003
Days to Decision 59 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
28d faster than avg
Panel avg: 87d · This submission: 59d
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 31
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K033299.
ROCHE FLUDI METHAMPHETAMINE
K093884 · Roche Diagnostics · Feb 2011
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242 · Lin-Zhi International, Inc. · Sep 2006
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577 · Immunalysis Corporation · Oct 2005
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
K023837 · Princeton BioMeditech Corp. · Sep 2003
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589 · ACON Laboratories, Inc. · Oct 2002
AMPHETAMINE/METHAMPHETAMINE
K012998 · Abbott Laboratories · Mar 2002