LAF · Gas Chromatography, Methamphetamine
Clinical Toxicology · 21 CFR 862.3610 · Class 2
Overview
| Product Code | LAF |
|---|---|
| Device Name | Gas Chromatography, Methamphetamine |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Classification Rationale
Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (20 of 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | Dec 22, 2021 | SESE |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Corporation | Dec 15, 2021 | SESE |
| K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers | Diatron Group | Jul 31, 2020 | SESE |
| K170222 | Rapid Tox Cup II | American Bio Medica Corp. | Aug 15, 2017 | SESE |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | Mar 18, 2016 | SESE |
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls | Biophor Diagnostics, Inc. | Sep 18, 2015 | SESE |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | Mar 4, 2015 | SESE |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | Feb 26, 2015 | SESE |
| K133047 | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU | Biophor Diagnostics, Inc. | Dec 18, 2014 | SESE |
| K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | Lin-Zhi International, Inc. | Mar 21, 2014 | SESE |
| K111927 | PSYCHEMEDICS METHAMPHETAMINE EIA | Psychemedics Corp. | May 1, 2012 | SESE |
| K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | Lin-Zhi International, Inc. | Jan 23, 2012 | SESE |
| K112236 | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | Sep 19, 2011 | SESE |
| K101973 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) | Omega Laboratories, Inc. | Aug 16, 2011 | SESE |
| K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | Microgenics Corp. | Apr 8, 2011 | SESE |
| K093884 | ROCHE FLUDI METHAMPHETAMINE | Roche Diagnostics | Feb 25, 2011 | SESE |
| K080455 | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 | Quantrx Biomedical Corporation | Dec 31, 2008 | SESE |
| K080381 | QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA | Quest Diagnostics, Inc. | Jun 25, 2008 | SESE |
| K062242 | METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Sep 29, 2006 | SESE |
| K051577 | IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS | Immunalysis Corporation | Oct 4, 2005 | SESE |
Top Applicants
- Phamatech — 4 clearances
- ACON Laboratories, Inc. — 3 clearances
- Diagnostic Products Corp. — 3 clearances
- Immunalysis Corporation — 3 clearances
- Lin-Zhi International, Inc. — 3 clearances
