Product Code: LAF FDA class 2 21 CFR 862.3610

Gas Chromatography, Methamphetamine

Clinical Toxicology

Gas chromatography for methamphetamine detection is an analytical method used in clinical toxicology laboratories to identify and measure methamphetamine concentrations in patient specimens. It is classified as FDA Class 2, indicating moderate risk with a requirement for 510(k) premarket clearance. The product code is LAF, regulated under 21 CFR 862.3610, in the Clinical Toxicology specialty. Third-party review eligibility applies.

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FEI Numbers

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Basic Information

Product Code: LAF
Device Class: FDA class 2
Regulation Number: 862.3610
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203647	SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay	Dec 22, 2021	Substantially Equivalent	Immunalysis Corporation
K210212	Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair	Dec 15, 2021	Substantially Equivalent	Psychemedics Corporation
K201442	Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers	Jul 31, 2020	Substantially Equivalent	Diatron Group
K170222	Rapid Tox Cup II	Aug 15, 2017	Substantially Equivalent	American Bio Medica Corp.
K153693	Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Mar 18, 2016	Substantially Equivalent	Immunalysis Corporation
K142293	Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls	Sep 18, 2015	Substantially Equivalent	Biophor Diagnostics, Inc.
K150096	Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)	Mar 04, 2015	Substantially Equivalent	Healgen Scientific,, LLC
K150162	First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test	Feb 26, 2015	Substantially Equivalent	W.H.P.M., Inc.
K133047	RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU	Dec 18, 2014	Substantially Equivalent	Biophor Diagnostics, Inc.
K131652	LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS	Mar 21, 2014	Substantially Equivalent	Lin-Zhi International, Inc.
K111927	PSYCHEMEDICS METHAMPHETAMINE EIA	May 01, 2012	Substantially Equivalent	Psychemedics Corp.
K113661	LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS	Jan 23, 2012	Substantially Equivalent	Lin-Zhi International, Inc.
K112236	WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST	Sep 19, 2011	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K101973	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)	Aug 16, 2011	Substantially Equivalent	Omega Laboratories, Inc.
K101753	THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY	Apr 08, 2011	Substantially Equivalent	Microgenics Corp.
K093884	ROCHE FLUDI METHAMPHETAMINE	Feb 25, 2011	Substantially Equivalent	Roche Diagnostics
K080455	RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050	Dec 31, 2008	Substantially Equivalent	Quantrx Biomedical Corporation
K080381	QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA	Jun 25, 2008	Substantially Equivalent	Quest Diagnostics, Inc.
K062242	METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS	Sep 29, 2006	Substantially Equivalent	Lin-Zhi International, Inc.
K051577	IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS	Oct 04, 2005	Substantially Equivalent	Immunalysis Corporation
K033299	ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE	Dec 12, 2003	Substantially Equivalent	ACON Laboratories, Inc.
K023837	LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA	Sep 15, 2003	Substantially Equivalent	Princeton BioMeditech Corp.
K023101	AMEDICA DRUG SCREEN METHAPHETAMINE TEST	Dec 16, 2002	Substantially Equivalent	Amedica Biotech, Inc.
K022589	ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE	Oct 28, 2002	Substantially Equivalent	ACON Laboratories, Inc.
K012998	AMPHETAMINE/METHAMPHETAMINE	Mar 13, 2002	Substantially Equivalent	Abbott Laboratories
K012585	AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE	Nov 16, 2001	Substantially Equivalent	Ameditech, Inc.
K011672	ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE	Jul 31, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K011610	LIVESURE METHAMPHETAMINE SCREEN TESTS	Jun 08, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K010496	CEDIA DAU AMPHETAMINES/ECSTASY ASSAY	May 29, 2001	Substantially Equivalent	Microgenics Corp.
K003847	MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K003845	MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K010836	AT WORK DRUG TEST, MODEL 9147T AWT	Apr 11, 2001	Substantially Equivalent	Phamatech
K003352	ESCREEN SYSTEM	Mar 20, 2001	Substantially Equivalent	Escreen, Inc.
K993852	FIRST CHECK HOME DRUG TEST PANEL 4	Nov 29, 2000	Substantially Equivalent	Worldwide Medical Corp.
K000096	ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686	Apr 26, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K000452	SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST	Apr 24, 2000	Substantially Equivalent	Drug Detection Devices, Ltd.
K000979	REDI-SCREEN	Apr 10, 2000	Substantially Equivalent	Redwood Biotech, Inc.
K993208	STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I	Apr 03, 2000	Substantially Equivalent	OraSure Technologies, Inc.
K000447	QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225	Mar 07, 2000	Substantially Equivalent	Phamatech
K993982	SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL	Jan 27, 2000	Substantially Equivalent	Syva Co.
K992634	IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5	Jan 20, 2000	Substantially Equivalent	Diagnostic Products Corp.
K994233	AT HOME DRUG TEST, MODEL 9068	Dec 30, 1999	Substantially Equivalent	Phamatech
K991504	REDI-TEST METHAMPHETAMINE	Jul 22, 1999	Substantially Equivalent	Redwood Biotech, Inc.
K983189	DBEST METHAMPHETAMINES TEST KIT	Nov 18, 1998	Substantially Equivalent	Ameritek, Inc.
K972556	QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)	Sep 02, 1997	Substantially Equivalent	Phamatech
K961249	ACCUSIGN MET/BIOSIGN MET	Apr 25, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K910043	TENONE(TM) METHAMPHETAMINE	Feb 14, 1991	Substantially Equivalent	Diagnostic Products Corp.
K904413	CEDIA(TM) PHENOBARBITAL ASSAY	Nov 05, 1990	Substantially Equivalent	Microgenics Corp.
K885071	COAT-A-COUNT METHAMPHETAMIN #TKMA1	Jan 09, 1989	Substantially Equivalent	Diagnostic Products Corp.