Cleared Traditional

K062242 - METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY

Also marketed or referenced as:
CALIBRATORS AND CONTROLS

K062242 is an FDA 510(k) clearance for METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ..., manufactured by Lin-Zhi International, Inc.. The device is a Class 2 Chemistry device with product code LAF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K062242 · Lin-Zhi International, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
58d
Days
Class 2
Risk

K062242 is an FDA 510(k) clearance for the METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on September 29, 2006 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3610 - the FDA in vitro diagnostics and chemistry 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.

FDA 510(k) Submission Details - K062242

510(k) Number K062242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2006
Decision Date September 29, 2006
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 89d · This submission: 58d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LAF Gas Chromatography, Methamphetamine

All 48
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K062242.
ROCHE FLUDI METHAMPHETAMINE
K093884 · Roche Diagnostics · Feb 2011
RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
K080455 · Quantrx Biomedical Corporation · Dec 2008
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
K080381 · Quest Diagnostics, Inc. · Jun 2008
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577 · Immunalysis Corporation · Oct 2005
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299 · ACON Laboratories, Inc. · Dec 2003
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
K023837 · Princeton BioMeditech Corp. · Sep 2003
K062242 · METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
Download PDF FDA Summary Lin-Zhi International…