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 Diagnostic Products Corp., Immunalysis Corporation and Psychemedics Corporation.

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 13, 2002
AMPHETAMINE/METHAMPHETAMINE
K012998
Abbott Laboratories
Toxicology · 188d
Cleared Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096
Roche Diagnostics Corp.
Toxicology · 104d
Cleared Jan 27, 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982
Syva Co.
Toxicology · 64d
Cleared Jan 20, 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634
Diagnostic Products Corp.
Toxicology · 167d
Cleared Feb 14, 1991
TENONE(TM) METHAMPHETAMINE
K910043
Diagnostic Products Corp.
Toxicology · 41d
Cleared Jan 09, 1989
COAT-A-COUNT METHAMPHETAMIN #TKMA1
K885071
Diagnostic Products Corp.
Toxicology · 32d

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.