Cleared Traditional

K033299 - ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE

K033299 is an FDA 510(k) clearance for ACON MAMP ONE STEP METHAMPHETAMINE TEST..., manufactured by ACON Laboratories, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K033299

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.

LAF Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K033299.
ROCHE FLUDI METHAMPHETAMINE
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K012998 · Abbott Laboratories · Mar 2002