Gas Chromatography, Methamphetamine
FDA product code LAF · Class II (moderate risk) · 21 CFR 862.3610 · Clinical Toxicology
49510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Phamatech 4
- Microgenics Corp. 3
- Diagnostic Products Corp. 3
- Lin-Zhi International, Inc. 3
- Immunalysis Corporation 3
- ACON Laboratories, Inc. 3
- Psychemedics Corp. 2
- Biophor Diagnostics, Inc. 2
- Alfa Scientific Designs, Inc. 2
- Roche Diagnostics Corp. 2
- Redwood Biotech, Inc. 2
- Princeton BioMeditech Corp. 2
- Worldwide Medical Corp. 1
- Escreen, Inc. 1
- Drug Detection Devices, Ltd. 1
- Pan Probe Biotech, Inc. 1
- OraSure Technologies, Inc. 1
- Diatron Group 1
- Abbott Laboratories 1
- Syva Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | Immunalysis Corporation | 12/22/2021SE |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairLAF · Traditional | Psychemedics Corporation | 12/15/2021SE |
| K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersLAF · Traditional | Diatron Group | 07/31/2020SE |
| K170222 | Rapid Tox Cup IILAF · Traditional | American Bio Medica Corp. | 08/15/2017SE |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF · Traditional | Immunalysis Corporation | 03/18/2016SE |
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…LAF · Traditional | Biophor Diagnostics, Inc. | 09/18/2015SE |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test…LAF · Traditional | Healgen Scientific,, LLC | 03/04/2015SE |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF · Traditional | W.H.P.M., Inc. | 02/26/2015SE |
| K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…LAF · Traditional | Biophor Diagnostics, Inc. | 12/18/2014SE |
| K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLAF · Traditional | Lin-Zhi International, Inc. | 03/21/2014SE |
| K111927 | Psychemedics Methamphetamine EiaLAF · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K113661 | Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi…LAF · Traditional | Lin-Zhi International, Inc. | 01/23/2012SE |
| K112236 | Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine TestLAF · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/19/2011SE |
| K101973 | Omega Laboratories Hair Drug Screening Assay for Methamphetamine and…LAF · Traditional | Omega Laboratories, Inc. | 08/16/2011SE |
| K101753 | Thermo Scientific Cedia Methamphetamine Oft AssayLAF · Traditional | Microgenics Corp. | 04/08/2011SE |
| K093884 | Roche Fludi MethamphetamineLAF · Traditional | Roche Diagnostics | 02/25/2011SE |
| K080455 | Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050LAF · Traditional | Quantrx Biomedical Corporation | 12/31/2008SE |
| K080381 | Quest Diagnostics Methamphetamine Micro-Plate EiaLAF · Traditional | Quest Diagnostics, Inc. | 06/25/2008SE |
| K062242 | Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLAF · Traditional | Lin-Zhi International, Inc. | 09/29/2006SE |
| K051577 | Immunalysis Methamphetamine Elisa for Oral FluidsLAF · Traditional | Immunalysis Corporation | 10/04/2005SE |
| K033299 | Acon Mamp One Step Methamphetamine Test Strip and Test DeviceLAF · Traditional | ACON Laboratories, Inc. | 12/12/2003SE |
| K023837 | Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma…LAF · Traditional | Princeton BioMeditech Corp. | 09/15/2003SE |
| K023101 | Amedica Drug Screen Methaphetamine TestLAF · Traditional | Amedica Biotech, Inc. | 12/16/2002SE |
| K022589 | Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test DeviceLAF · Traditional | ACON Laboratories, Inc. | 10/28/2002SE |
| K012998 | Amphetamine/MethamphetamineLAF · Traditional | Abbott Laboratories | 03/13/2002SE |
| K012585 | Ameditech Immutest Drug Screen MethamphetamineLAF · Traditional | Ameditech, Inc. | 11/16/2001SE |
| K011672 | Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test…LAF · Traditional | ACON Laboratories, Inc. | 07/31/2001SE |
| K011610 | Livesure Methamphetamine Screen TestsLAF · Traditional | Pan Probe Biotech, Inc. | 06/08/2001SE |
| K010496 | Cedia Dau Amphetamines/Ecstasy AssayLAF · Traditional | Microgenics Corp. | 05/29/2001SE |
| K003847 | Modification to Instant-View Methamphetyamine (METH1000) Urine Test (Cassette)LAF · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K003845 | Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip)LAF · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K010836 | At Work Drug Test, Model 9147T AwtLAF · Special | Phamatech | 04/11/2001SE |
| K003352 | Escreen SystemLAF · Traditional | Escreen, Inc. | 03/20/2001SE |
| K993852 | First Check Home Drug Test Panel 4LAF · Traditional | Worldwide Medical Corp. | 11/29/2000SE |
| K000096 | Ontrak Teststik for Methamphetamine, Cat. 1986686LAF · Traditional | Roche Diagnostics Corp. | 04/26/2000SE |
| K000452 | Screeners Methamphetamine Test, Drugscreen Dip Methamphetamine TestLAF · Traditional | Drug Detection Devices, Ltd. | 04/24/2000SE |
| K000979 | Redi-ScreenLAF · Special | Redwood Biotech, Inc. | 04/10/2000SE |
| K993208 | STC Methamphetamine Intercept Micro-Plate Eia, Model 1104ILAF · Traditional | OraSure Technologies, Inc. | 04/03/2000SE |
| K000447 | Quickscreen Methamphetamine Test, Models 9045, 9046, Quickscreen Pro Multi Drug…LAF · Special | Phamatech | 03/07/2000SE |
| K993982 | Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129ULLAF · Traditional | Syva Co. | 01/27/2000SE |
| K992634 | Immulite Methamphetamine, Model LKMA1, LKMA5LAF · Traditional | Diagnostic Products Corp. | 01/20/2000SE |
| K994233 | At Home Drug Test, Model 9068LAF · Special | Phamatech | 12/30/1999SE |
| K991504 | Redi-Test MethamphetamineLAF · Traditional | Redwood Biotech, Inc. | 07/22/1999SE |
| K983189 | Dbest Methamphetamines Test KitLAF · Traditional | Ameritek, Inc. | 11/18/1998SE |
| K972556 | Quickscreen One Step Methamphetamine TEST(9065)LAF · Traditional | Phamatech | 09/02/1997SE |
| K961249 | Accusign Met/Biosign MetLAF · Traditional | Princeton BioMeditech Corp. | 04/25/1996SE |
| K910043 | Tenone(Tm) MethamphetamineLAF · Traditional | Diagnostic Products Corp. | 02/14/1991SE |
| K904413 | Cedia(Tm) Phenobarbital AssayLAF · Traditional | Microgenics Corp. | 11/05/1990SE |
| K885071 | Coat-A-Count Methamphetamin #TKMA1LAF · Traditional | Diagnostic Products Corp. | 01/09/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1183-2021 Class III | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of…Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the… | OraSure Technologies, Inc. | 02/05/2021Terminated |