LAF · Class II · 21 CFR 862.3610

FDA Product Code LAF: Gas Chromatography, Methamphetamine

Gas chromatography provides definitive confirmation of methamphetamine in forensic and clinical samples. FDA product code LAF covers gas chromatography systems for methamphetamine quantification.

These analytical instruments separate and quantify methamphetamine and amphetamine by gas chromatographic separation followed by mass spectrometry or other detection, providing definitive confirmation after immunoassay screening.

LAF devices are Class II medical devices, regulated under 21 CFR 862.3610 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Phamatech, Diagnostic Products Corp. and Microgenics Corp..

49
Total
49
Cleared
148d
Avg days
1989
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Gas Chromatography, Methamphetamine Devices (Product Code LAF)

49 devices
1–24 of 49
Cleared Dec 22, 2021
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
K203647
Immunalysis Corporation
Toxicology · 373d
Cleared Dec 15, 2021
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
K210212
Psychemedics Corporation
Toxicology · 322d
Cleared Jul 31, 2020
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
K201442
Diatron Group
Toxicology · 60d
Cleared Aug 15, 2017
Rapid Tox Cup II
K170222
American Bio Medica Corp.
Toxicology · 202d
Cleared Mar 18, 2016
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K153693
Immunalysis Corporation
Toxicology · 86d
Cleared Mar 04, 2015
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
K150096
Healgen Scientific, LLC
Toxicology · 43d
Cleared Mar 21, 2014
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131652
Lin-Zhi International, Inc.
Toxicology · 289d
Cleared Jan 23, 2012
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
K113661
Lin-Zhi International, Inc.
Chemistry · 41d
Cleared Sep 19, 2011
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
K112236
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 46d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K101753
Microgenics Corp.
Chemistry · 290d
Cleared Feb 25, 2011
ROCHE FLUDI METHAMPHETAMINE
K093884
Roche Diagnostics
Toxicology · 434d
Cleared Sep 29, 2006
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242
Lin-Zhi International, Inc.
Chemistry · 58d
Cleared Oct 04, 2005
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577
Immunalysis Corporation
Toxicology · 112d
Cleared Dec 12, 2003
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Sep 15, 2003
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
K023837
Princeton BioMeditech Corp.
Toxicology · 301d
Cleared Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589
ACON Laboratories, Inc.
Chemistry · 84d
Cleared Mar 13, 2002
AMPHETAMINE/METHAMPHETAMINE
K012998
Abbott Laboratories
Toxicology · 188d
Cleared Jul 31, 2001
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
K011672
ACON Laboratories, Inc.
Toxicology · 62d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845
Alfa Scientific Designs, Inc.
Toxicology · 168d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
K003847
Alfa Scientific Designs, Inc.
Toxicology · 168d
Cleared May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496
Microgenics Corp.
Toxicology · 97d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836
Phamatech
Toxicology · 22d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096
Roche Diagnostics Corp.
Toxicology · 104d
Cleared Mar 07, 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
K000447
Phamatech
Toxicology · 26d

About Product Code LAF - Regulatory Context

510(k) Submission Activity

49 total 510(k) submissions under product code LAF since 1989, with 49 receiving FDA clearance (average review time: 148 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.