Enzyme Immunoassay, Amphetamine
FDA product code DKZ · Class II (moderate risk) · 21 CFR 862.3100 · Clinical Toxicology
225510(k) clearances
0PMA approvals
24recalls
Manufacturers
- Roche Diagnostic Systems, Inc. 17
- Syva Co. 13
- Roche Diagnostics Corp. 10
- Ucp Biosciences, Inc. 9
- American Bio Medica Corp. 9
- Abbott Laboratories 8
- Microgenics Corp. 8
- Biosite Incorporated 7
- ACON Laboratories, Inc. 6
- Alfa Scientific Designs, Inc. 6
- Guangzhou Wondfo Biotech Co., Ltd. 6
- Phamatech 6
- Diagnostic Products Corp. 5
- Ameditech Inc 5
- Lin-Zhi International, Inc. 5
- Drial Consultants, Inc. 5
- Dade Behring, Inc. 5
- Medtox Diagnostics, Inc. 3
- Sun Biomedical Laboratories, Inc. 3
- Branan Medical Corp. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240670 | DRI Ecstasy Plus AssayDKZ · Special | Microgenics Corporation | 10/30/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 12/13/2023SE |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen DipcardDKZ · Traditional | Xenta Biomedical Science Co., Ltd. | 05/19/2023SE |
| K200363 | Quidel Triage® TOX Drug Screen, 94600DKZ · Special | Quidel Cardiovascular, Inc. | 03/11/2020SE |
| K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelDKZ · Traditional | Atlas Medical | 10/03/2019SE |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProDKZ · Traditional | Quidel Cardiovascular, Inc. | 06/19/2019SE |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 03/27/2019SE |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug…DKZ · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/14/2018SE |
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | Phamatech, Inc. | 10/18/2018SE |
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | Alfa Scientific Designs, Inc. | 02/23/2018SE |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsDKZ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 08/30/2016SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | Alfa Scientific Designs, Inc. | 06/24/2016SE |
| K152908 | Ucp Compact Drug TestsDKZ · Traditional | Ucp Biosciences, Inc. | 05/03/2016SE |
| K152590 | ACCU NEWS Drug Screening Test Card/Urine CupDKZ · Traditional | Coretests, Inc. | 04/15/2016SE |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)…DKZ · Traditional | Assure Tech. (Hangzhou) Co, Ltd. | 03/31/2016SE |
| K152269 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip…DKZ · Traditional | Healgen Scientific,, LLC | 09/09/2015SE |
| K151213 | UCP Drug Test Mini CupsDKZ · Special | Ucp Biosciences, Inc. | 08/21/2015SE |
| K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3…DKZ · Traditional | Omega Laboratories, Inc. | 07/28/2015SE |
| K141748 | Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator…DKZ · Traditional | Biophor Diagnostics, Inc. | 05/20/2015SE |
| K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…DKZ · Traditional | Immunalysis Corporation | 02/06/2015SE |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardDKZ · Traditional | Co-Innovation Biotech Co., Ltd. | 12/11/2014SE |
| K142580 | Chemtrue Multi-Panel DOA DIP Card TestsDKZ · Special | Chemtron Biotech, Inc. | 12/01/2014SE |
| K141532 | CR3 Keyless Split Sample Cup Amphetamine-CocaineDKZ · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 07/14/2014SE |
| K131069 | Quickscreen Amphetine 500 TestDKZ · Traditional | Phamatech, Inc. | 05/14/2014SE |
| K132812 | Ucp Multi-Drug Test Key CupsDKZ · Traditional | Ucp Biosciences, Inc. | 03/06/2014SE |
| K133968 | Wondfo Multi-Drug Urine Test Cup, PanelDKZ · Special | Guangzhou Wondfo Biotech Co., Ltd. | 02/25/2014SE |
| K131653 | Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsDKZ · Traditional | Lin-Zhi International, Inc. | 02/04/2014SE |
| K131110 | One Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test DipcardDKZ · Traditional | Co-Innovation Biotech Co., Ltd. | 01/15/2014SE |
| K130082 | Genprime Drugs of Abuse Reader SystemDKZ · Traditional | Genprime, Inc. | 12/20/2013SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | Alfa Scientific Designs, Inc. | 10/07/2013SE |
| K131811 | Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsDKZ · Special | Ucp Biosciences, Inc. | 07/19/2013SE |
| K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and CupDKZ · Traditional | Advin Biotech | 06/17/2013SE |
| K121065 | Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of…DKZ · Traditional | Polymed Therapeutics, Inc. | 05/24/2013SE |
| K130463 | Ucp Home Drug Screening Test; Cards, CupsDKZ · Traditional | Ucp Biosciences, Inc. | 05/15/2013SE |
| K130811 | Psychemedics Microplate Eia for AmphetamineDKZ · Traditional | Psychemedics Corp. | 05/02/2013SE |
| K123863 | Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsDKZ · Special | Ucp Biosciences, Inc. | 01/09/2013SE |
| K122961 | Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500)DKZ · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 12/21/2012SE |
| K122419 | Ucp Home Drug Screening Test CupsDKZ · Traditional | Ucp Biosciences, Inc. | 11/30/2012SE |
| K122904 | Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU…DKZ · Special | Guangzhou Wondfo Biotech Co., Ltd. | 11/15/2012SE |
| K121987 | Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo Benzodiazepines…DKZ · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 08/01/2012SE |
| K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsDKZ · Traditional | Chemtron Biotech, Inc. | 05/17/2012SE |
| K113046 | Ameditech Immutest Milti-Drug ScreenDKZ · Special | Ameditech, Inc. | 11/10/2011SE |
| K111560 | Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiazepines…DKZ · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 07/15/2011SE |
| K110446 | Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat…DKZ · Traditional | Roche Diagnostics | 05/03/2011SE |
| K101745 | Thermo Scientific Cedia Amphetamine Oft AssayDKZ · Traditional | Microgenics Corp. | 04/08/2011SE |
| K092275 | Randox Ecstasy (Mdma) AssayDKZ · Traditional | Randox Laboratories, Ltd. | 03/01/2011SE |
| K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsDKZ · Traditional | Chemtron Biotech, Inc. | 01/20/2011SE |
| K102210 | Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators…DKZ · Traditional | Lin-Zhi International, Inc. | 12/28/2010SE |
| K093664 | Amphetamines II AssayDKZ · Traditional | Roche Diagnostics Corp. | 07/28/2010SE |
| K093114 | Thermo Scientific Dri Amphetamines AssayDKZ · Traditional | Microgenics Corp. | 05/12/2010SE |
| K083764 | Amphetamines IIDKZ · Traditional | Roche Diagnostics Corp. | 02/03/2010SE |
| K091588 | Ucp Home Drug Screening TestsDKZ · Traditional | Ucp Biosciences, Inc. | 09/04/2009SE |
| K080635 | MedtoxscanDKZ · Traditional | Medtox Diagnostics, Inc. | 02/13/2009SE |
| K080057 | Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep ControlDKZ · Traditional | Novx Systems, Inc. | 10/31/2008SE |
| K071489 | Homecheck Multiple Drug Cup TestDKZ · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 03/28/2008SE |
| K063379 | Amedica Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma, Bar, Bzo, M, Models C1210, C1220DKZ · Special | Amedica Biotech, Inc. | 12/11/2006SE |
| K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…DKZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/22/2006SE |
| K061617 | Forsure One Step Dip & Read (X) Drug Screen TestDKZ · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 11/22/2006SE |
| K061718 | Innovacon Spectrum II Test CardDKZ · Special | Innovacon, Inc. | 11/13/2006SE |
| K063024 | Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…DKZ · Traditional | Lin-Zhi International, Inc. | 10/30/2006SE |
| K061005 | Accustep Doa Single and Multi-Strip Screen PanelsDKZ · Traditional | Applied Dna Technologies, Inc. | 10/04/2006SE |
| K060810 | One Step Drug Test - Amp/Met/Mor/Thc/CocDKZ · Traditional | Ind Diagnostic, Inc. | 08/07/2006SE |
| K053359 | RapidtoxDKZ · Special | American Bio Medica Corp. | 05/25/2006SE |
| K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109DKZ · Traditional | Dade Behring, Inc. | 05/19/2006SE |
| K052882 | Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup DeviceDKZ · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 02/15/2006SE |
| K053032 | Acro Biotech LLC Rapid Amphetamine Urine Test; Catalog# AMP001000DKZ · Traditional | Acro Biotech, LLC | 02/09/2006SE |
| K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…DKZ · Traditional | First Check Diagnostics, LLC | 12/29/2005SE |
| K053175 | Ameditech DrugsmartcupDKZ · Special | Ameditech, Inc. | 12/08/2005SE |
| K051161 | Quest Diagnostics Haircheck-Dt (Amphetamines)DKZ · Traditional | Quest Diagnostics, Inc. | 11/22/2005SE |
| K050394 | Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone…DKZ · Traditional | Medtox Diagnostics, Inc. | 10/25/2005SE |
| K051579 | Immunalysis Amphetamine Elisa for Oral FluidsDKZ · Traditional | Immunalysis Corporation | 10/21/2005SE |
| K051966 | First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…DKZ · Traditional | Worldwide Medical, LLC | 09/07/2005SE |
| K041696 | Rapid ReaderDKZ · Traditional | American Bio Medica Corp. | 07/12/2005SE |
| K051235 | On Trak TestcardDKZ · Special | Varian, Inc. | 06/08/2005SE |
| K050540 | Ucp Rapid Drug Screening TestsDKZ · Traditional | Ucp Biosciences, Inc. | 04/29/2005SE |
| K050186 | Ameditech Immutest Multi-Drug Screen Panel IIIDKZ · Traditional | Ameditech, Inc. | 03/04/2005SE |
| K043028 | Emit II Plus Ecstasy AssayDKZ · Traditional | Dade Behring, Inc. | 01/07/2005SE |
| K041822 | Acon Amp 300 One Step Amphetamine Test Strip and DeviceDKZ · Traditional | ACON Laboratories, Inc. | 09/16/2004SE |
| K041743 | Acon Tri-Fect Drug Screen Test DeviceDKZ · Traditional | ACON Laboratories, Inc. | 09/09/2004SE |
| K041685 | Acon Multi-Clin Drug Screen Test DeviceDKZ · Traditional | ACON Laboratories, Inc. | 08/30/2004SE |
| K033743 | Cozart Eia Amphetamines Oral Fluid Microplate KitDKZ · Traditional | Cozart Bioscience , Ltd. | 06/03/2004SE |
| K032575 | First Sign Drug of Abuse Screening TestDKZ · Traditional | W.H.P.M., Inc. | 05/19/2004SE |
| K033566 | Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062DKZ · Traditional | Rapid Diagnostics, Inc. | 05/17/2004SE |
| K040350 | Randox Amphetamine Class AssayDKZ · Traditional | Randox Laboratories, Ltd. | 05/12/2004SE |
| K040133 | Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDKZ · Traditional | Dade Behring, Inc. | 04/08/2004SE |
| K040203 | Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen…DKZ · Traditional | Branan Medical Corp. | 03/25/2004SE |
| K040092 | Ameditech Immu Test Drug Screen PanelDKZ · Special | Ameditech, Inc. | 03/08/2004SE |
| K033902 | Ontrak Testcup II and Onsite CupkitDKZ · Special | Varian, Inc. | 01/20/2004SE |
| K033659 | Varian, Inc. Ontrak Testcup and Ontrak TeststikDKZ · Traditional | Varian, Inc. | 01/06/2004SE |
| K033094 | Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit)DKZ · Traditional | Lin-Zhi International, Inc. | 12/19/2003SE |
| K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…DKZ · Special | ACON Laboratories, Inc. | 08/04/2003SE |
| K031004 | Syva Emit II Plus Amphetamines AssayDKZ · Traditional | Dade Behring, Inc. | 06/06/2003SE |
| K023712 | Advantage Multiple Drugs of Abuse TestDKZ · Traditional | Advantage Diagnostics Corp. | 01/31/2003SE |
| K023104 | Amedica Drug Screen Amphetamine TestDKZ · Traditional | Amedica Biotech, Inc. | 12/16/2002SE |
| K022564 | Instant-View Multi-Drug Screen Urine TestDKZ · Special | Alfa Scientific Designs, Inc. | 08/30/2002SE |
| K021114 | 'Rapidtec' 5A Multiple Dip TestDKZ · Traditional | American Bio Medica Corp. | 07/23/2002SE |
| K020869 | First Check Home Drug Test for Mdma (Ecstasy)DKZ · Traditional | Worldwide Medical Corp. | 06/11/2002SE |
| K021006 | Startox Drug of Abuse Screening TestDKZ · Traditional | Starplex Scientific, Inc. | 06/10/2002SE |
| K020395 | Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000…DKZ · Traditional | Lin-Zhi International, Inc. | 06/04/2002SE |
| K014247 | Triage Drugs of Abuse Panel Plus PPX, Model Catalog 92002DKZ · Traditional | Biosite Incorporated | 06/03/2002SE |
| K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…DKZ · Traditional | Acon Laboratories Co. | 05/08/2002SE |
| K012745 | Triage Tox Drug Screen, Catalog #94000DKZ · Traditional | Biosite Incorporated | 01/10/2002SE |
| K012484 | Ameditech Immutest Drug Screen AmphetamineDKZ · Traditional | Ameditech, Inc. | 11/30/2001SE |
| K012396 | Ontrak Testcard 9DKZ · Abbreviated | Roche Diagnostics Corp. | 11/05/2001SE |
| K011952 | Drugs of Abuse Multi-Test StripDKZ · Traditional | Microdiagnostics, Inc. | 10/25/2001SE |
| K012110 | Dri Ecstasy Enzyme ImmunoassayDKZ · Traditional | Microgenics Corp. | 08/27/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | Syva Co. | 08/03/2001SE |
| K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test DeviceDKZ · Traditional | ACON Laboratories, Inc. | 07/31/2001SE |
| K012159 | Rapid Drug ScreenDKZ · Special | American Bio Medica Corp. | 07/25/2001SE |
| K011499 | Visualine Amphetamine Dipstrip AssayDKZ · Traditional | Sun Biomedical Laboratories, Inc. | 07/17/2001SE |
| K011609 | Livesure Amphetamine Screen TestDKZ · Traditional | Pan Probe Biotech, Inc. | 06/08/2001SE |
| K010177 | Visualine II (Also Known AS Sunline) Amphetamine AssayDKZ · Traditional | Sun Biomedical Laboratories, Inc. | 05/17/2001SE |
| K003809 | Rapid Drugs of Abuse Single and Multiple Test PanelsDKZ · Traditional | Rapid Diagnostics, Inc. | 04/20/2001SE |
| K010564 | Verdict -Ii Thc/Coc/Opi/Amp/Pcp/Bar/Bzo & Thc/Coc/Bar/Bzo; Profile -Ii 7…DKZ · Special | Medtox Diagnostics, Inc. | 04/05/2001SE |
| K010645 | At Home Drug Test, Model 9063 TDKZ · Special | Phamatech | 03/30/2001SE |
| K004034 | Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12DKZ · Traditional | Branan Medical Corp. | 03/08/2001SE |
| K003865 | Cobas Integra AmphetaminesDKZ · Traditional | Roche Diagnostics Corp. | 02/28/2001SE |
| K002266 | Branan Medical Corporation Monitect Amphetamine Drug Screen TestDKZ · Traditional | Branan Medical Corporation | 11/22/2000SE |
| K002447 | Modification to Rapid Drug Screen 9-PANELDKZ · Traditional | American Bio Medica Corp. | 11/16/2000SE |
| K994395 | Instant-View Amphetamine Urine Cassette TestDKZ · Traditional | Alfa Scientific Designs, Inc. | 08/07/2000SE |
| K994399 | Instant-View Amphetamine Urine Dip Strip TestDKZ · Traditional | Alfa Scientific Designs, Inc. | 08/04/2000SE |
| K001421 | Ontrak Testcup 501, Model 3016633DKZ · Special | Roche Diagnostics Corp. | 07/12/2000SE |
| K001417 | Ontrak Testcup 502, Model 3016641DKZ · Special | Roche Diagnostics Corp. | 06/29/2000SE |
| K001397 | Quickscreen Pro Drug Cup, Model 9195XDKZ · Special | Phamatech | 05/26/2000SE |
| K001225 | Accusign Amp 300, Biosign Amp 300, Status DS Amp 300, Syva Rapid Test D.A.U.DKZ · Special | Princeton BioMeditech Corp. | 05/17/2000SE |
| K000606 | Synchron Systems Amphetamine ReagentDKZ · Traditional | Beckman Coulter, Inc. | 05/05/2000SE |
| K994380 | Cedia Dau Amphassure AssayDKZ · Traditional | Microgenics Corp. | 05/02/2000SE |
| K000400 | Screeners Amphetamine Test, Drugscreen Dip Amphetamine TestDKZ · Traditional | Drug Detection Devices, Ltd. | 04/18/2000SE |
| K000460 | Urine Amphetamine/Methamphetamine (Amph) Screen Flex Reagent, Catalog No. DF 90ADKZ · Traditional | Dade Behring, Inc. | 04/14/2000SE |
| K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IDKZ · Traditional | OraSure Technologies, Inc. | 04/03/2000SE |
| K992632 | Immulite Amphetamine, Models LKAM1, LKAM5DKZ · Traditional | Diagnostic Products Corp. | 01/27/2000SE |
| K994237 | At Home Drug Test, Model 9063DKZ · Special | Phamatech | 12/30/1999SE |
| K990681 | Dbset Multidrug Screen Test KitDKZ · Traditional | Ameritek, Inc. | 07/15/1999SE |
| K992033 | Modification to 'Rapid Drug Screen' 9-PANELDKZ · Traditional | American Bio Medica Corp. | 06/30/1999SE |
| K990325 | Quikstrip Dipscan X Multidrug Screening DeviceDKZ · Traditional | Syntron Bioresearch, Inc. | 06/24/1999SE |
| K990399 | Ontrak Testcup M2K, Model Cat. 11 1849 8DKZ · Traditional | Roche Diagnostics Corp. | 04/15/1999SE |
| K990418 | Ontrak Testcup-Er M2KDKZ · Traditional | Roche Diagnostics Corp. | 04/13/1999SE |
| K984525 | Rapid Drug Screen 5-PANEL with Methamphetamine TestDKZ · Traditional | American Bio Medica Corp. | 02/26/1999SE |
| K990337 | Ontrak TESTCUP-5 M2KDKZ · Traditional | Roche Diagnostics Corp. | 02/23/1999SE |
| K983770 | 'Rapid Drug Screen' 9-PANELDKZ · Traditional | American Bio Medica Corp. | 12/31/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | Roche Diagnostic Systems, Inc. | 12/11/1998SE |
| K981705 | 'Rapid Drug Screen' 8 Panel-Low VolumeDKZ · Traditional | American Bio Medica Corp. | 08/27/1998SE |
| K981504 | Dbest Amphetamines Test KitDKZ · Traditional | Ameritek, Inc. | 08/06/1998SE |
| K981197 | One Step Urine Drug of Abuse Amphetamine TestDKZ · Traditional | Tcpi, Inc. | 06/16/1998SE |
| K980865 | Quickscreen Pro Multi Drug Screening Test , Model 9140-9147, 9061,9066, 9071, 9076, 9081…DKZ · Traditional | Phamatech | 04/01/1998SE |
| K974611 | Micro-Strip for Amphetamine MetabolitesDKZ · Traditional | Microdiagnostics, Inc. | 03/20/1998SE |
| K972989 | STC Methamphetamine Micro-Plate EiaDKZ · Traditional | OraSure Technologies, Inc. | 01/28/1998SE |
| K973784 | Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug…DKZ · Traditional | Biosite Incorporated | 12/03/1997SE |
| K973726 | Fingerprint Drug Screening DeviceDKZ · Traditional | Applied Technology Ventures, LLC | 11/06/1997SE |
| K973075 | Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for…DKZ · Traditional | Roche Diagnostic Systems, Inc. | 10/09/1997SE |
| K972891 | Abuscreen Online for Amphetamines with Periodate - Olympus AU800/1000 Instrument…DKZ · Traditional | Roche Diagnostic Systems, Inc. | 10/01/1997SE |
| K972032 | Visualine II MethamphetimineDKZ · Traditional | Sun Biomedical Laboratories, Inc. | 08/12/1997SE |
| K970395 | Quikstrip One Step MethamphetamineDKZ · Traditional | Drial Consultants, Inc. | 06/26/1997SE |
| K971218 | Quikstrip One Step Amphetamine TestDKZ · Traditional | Drial Consultants, Inc. | 05/30/1997SE |
| K971109 | Quikpac II One Step Amphetamine TestDKZ · Traditional | Drial Consultants, Inc. | 05/14/1997SE |
| K970724 | Quickpac II One Step Methamphetamine TestDKZ · Traditional | Drial Consultants, Inc. | 05/13/1997SE |
| K970265 | One Step Urine Drug of Abuse Methamphetamine TestDKZ · Traditional | Drial Consultants, Inc. | 04/08/1997SE |
| K962411 | Ontrak Testcup AmphetaminesDKZ · Traditional | Roche Diagnostic Systems, Inc. | 10/07/1996SE |
| K955934 | Triage Panel for Drugs of Abuse Model 9500/93000DKZ · Traditional | Biosite Incorporated | 02/16/1996SE |
| K955935 | Triage Panel for Drugs of Abuse/Tricyclic AntidepressantsDKZ · Traditional | Biosite Incorporated | 02/15/1996SE |
| K953115 | Axsym Amphetamine/Methamphetamine IIDKZ · Traditional | Abbott Laboratories | 10/06/1995SE |
| K935573 | Amphetamines Micro-Plate EiaDKZ · Traditional | Solarcare Technologies Corp,Inc. | 07/14/1995SE |
| K951154 | Cedia Dau Amphetamines AssayDKZ · Traditional | Microgenics Corp. | 05/08/1995SE |
| K942836 | Fingerprint-DoaDKZ · Traditional | Fingerprint Bioteck, Inc. | 05/01/1995SE |
| K945610 | Abusign(Tm) Amp, Doa-Amp, Accusign(Tm) Amp-Doa-Amp, Biosign(Tm) Amp, Doa-AmpDKZ · Traditional | Princeton BioMeditech Corp. | 04/13/1995SE |
| K950135 | Urine Amphetamines Screen Flex(Tm) Reagent CartridgeDKZ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/30/1995SE |
| K943439 | Abusign DOA4DKZ · Traditional | Princeton BioMeditech Corp. | 02/22/1995SE |
| K935352 | Emit(R) Iic Amphetamine AssayDKZ · Traditional | Syva Co. | 02/22/1995SE |
| K944604 | CX Amphetamines Reagent for Synchron CX SystemsDKZ · Traditional | Beckman-Diagnostic Systems Group | 12/07/1994SE |
| K943993 | Cedia Dau Amphetamines AssayDKZ · Traditional | Microgenics Corp. | 10/21/1994SE |
| K935052 | Microline Screen for AmphetamineDKZ · Traditional | Drug Screening Systems, Inc. | 09/16/1994SE |
| K941372 | Cedia Dau Amphetamines AssayDKZ · Traditional | Microgenics Corp. | 07/20/1994SE |
| K935042 | Roche Abuscreen Sample Oxidizing ReagentDKZ · Traditional | Roche Diagnostic Systems, Inc. | 01/25/1994SE |
| K934891 | Amphetamines Eia Assay ModificationDKZ · Traditional | Diagnostic Reagents, Inc. | 01/13/1994SE |
| K932304 | Micro Eia for Amphetamine MetabolitesDKZ · Traditional | Microdiagnostics, Inc. | 12/07/1993SE |
| K934693 | Amphetamine Test SystemDKZ · Traditional | U.S. Drug Testing, Inc. | 11/22/1993SE |
| K933052 | Abuscreen Online(R) for Amphetamines, ModifiedDKZ · Traditional | Roche Diagnostic Systems, Inc. | 09/15/1993SE |
| K931498 | Solarcare Technologies Corp. Microplate Amp. AssayDKZ · Traditional | Solarcare Technologies Corp,Inc. | 07/20/1993SE |
| K930690 | STC Diagnostics Auto-Lyte Amphetamines EiaDKZ · Traditional | Solarcare Technologies Corp,Inc. | 04/16/1993SE |
| K924476 | The Triage IIDKZ · Traditional | Biosite Incorporated | 01/22/1993SE |
| K921998 | Abuscreen(R) Online(Tm) for Amphetamines, ModifiedDKZ · Traditional | Roche Diagnostic Systems, Inc. | 05/26/1992SE |
| K921554 | Amphetamines Eia TestDKZ · Traditional | Diagnostic Reagents, Inc. | 05/04/1992SE |
| K920018 | Accuscreen AssayDKZ · Traditional | Jk Research | 03/19/1992SE |
| K920507 | Emit II Monoclonal Amphetamine/ Methamph. AssayDKZ · Traditional | Syva Co. | 02/27/1992SE |
| K913738 | Il Test(Tm) AmphetamineDKZ · Traditional | Instrumentation Laboratory CO | 11/07/1991SE |
| K914146 | Biosite Diagnostics-Triage Panel for Drugs AbuseDKZ · Traditional | Biosite Incorporated | 10/11/1991SE |
| K912758 | Abuscreen Online for AmphetaminesDKZ · Traditional | Roche Diagnostic Systems, Inc. | 07/26/1991SE |
| K910658 | Abuscreen Ontrak for MethamphetamineDKZ · Traditional | Roche Diagnostic Systems, Inc. | 04/03/1991SE |
| K910278 | Abuscreen(R) Ontrak(Tm) for AMPHETAMINE(500 Ng/Ml)DKZ · Traditional | Roche Diagnostic Systems, Inc. | 04/03/1991SE |
| K910739 | Target Amphetamine/Methamphetamine-R (Reader Meth)DKZ · Traditional | V-Tech, Inc. | 03/21/1991SE |
| K910738 | Target Amphetamine/Methamphetamine-V (Visual Meth)DKZ · Traditional | V-Tech, Inc. | 03/19/1991SE |
| K910756 | Abuscreen(R) FP for Methamphetamine (500-1000)DKZ · Traditional | Roche Diagnostic Systems, Inc. | 03/11/1991SE |
| K905700 | Ez-Screen: AmphetaminesDKZ · Traditional | Environmental Diagnostics, Inc. | 01/15/1991SE |
| K903993 | Microzyme(Tm) Methamphet/Amphet Enzyme Immuno KitDKZ · Traditional | Immunotech Corp. | 12/20/1990SE |
| K904115 | Hycor Accupinch Methamphetamine TestDKZ · Traditional | Hycor Biomedical, Inc. | 11/28/1990SE |
| K904451 | Milenia (TM) MethamphetamineDKZ · Traditional | Diagnostic Products Corp. | 11/21/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | Technicon Instruments Corp. | 09/27/1990SE |
| K902979 | Milenia (TM) AmphetamineDKZ · Traditional | Diagnostic Products Corp. | 09/07/1990SE |
| K900995 | Emit D.A.U. Amphetamine Class AssayDKZ · Traditional | Syva Co. | 04/20/1990SE |
| K900143 | Abuscreen FP for MethamphetamineDKZ · Traditional | Roche Diagnostic Systems, Inc. | 03/09/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1589-2022 Class II | Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN)…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-3050-2020 Class II | First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3049-2020 Class II | First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-3048-2020 Class II | First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600BVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all… | Ameditech Inc | 08/18/2020Terminated |
| Z-0418-2018 Class II | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25…The recalled lots have demonstrated unexpected false positive THC results. | Alere San Diego, Inc. | 11/14/2017Completed |
| Z-0073-2015 Class II | ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug…Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation… | Ameditech Inc | 09/23/2014Terminated |
| Z-0072-2015 Class II | ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug…Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation… | Ameditech Inc | 09/23/2014Terminated |
| Z-0071-2015 Class II | ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug…Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation… | Ameditech Inc | 09/23/2014Terminated |
| Z-2052-2013 Class II | SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | Sarken, Inc. | 07/29/2013Terminated |
| Z-2049-2013 Class II | SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY…These products are being recalled because they were distributed without adequate labeling and instructions… | Sarken, Inc. | 07/29/2013Terminated |
| Z-0653-2014 Class II | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug…Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may… | Alere San Diego, Inc. | 06/03/2013Terminated |
| Z-0521-2012 | Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay…The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage… | Alere San Diego | 07/01/2011Terminated |
| Z-2881-2011 | Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the…Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured… | Alere San Diego | 06/10/2011Terminated |
| Z-0152-2012 | ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen…The recall was initiated because Ameditech, Inc. received a complaint from US Diagnostics (USD) that First… | Ameditech Inc | 06/07/2011Terminated |
| Z-2670-2011 | SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a…The recall was initiated because Ameditech's internal review of regulatory files found that the two affected… | Ameditech Inc | 04/26/2011Terminated |
| Z-0010-2010 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A.…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | Biosite Inc | 04/27/2009Terminated |
| Z-0009-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | Biosite Inc | 04/27/2009Terminated |
| Z-0008-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | Biosite Inc | 04/27/2009Terminated |
| Z-0007-2010 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | Biosite Inc | 04/27/2009Terminated |
| Z-0006-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | Biosite Inc | 04/27/2009Terminated |
| Z-1088-2009 | Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for…The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all… | Biosite Inc | 11/06/2008Terminated |
| Z-2202-2008 | MEDTOXscan ReaderReader was marketed without a 510(k). | Medtox Diagnostics Inc | 02/08/2008Terminated |
| Z-1462-2008 | AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La…Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after… | Abbott Laboratories | 01/21/2008Terminated |
| Z-0733-2007 | Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is…The product may produce a faint line which could be interpreted as a false negative test result . | Bio-Rad Laboratories Inc | 02/12/2007Terminated |