Enzyme Immunoassay, Barbiturate
FDA product code DIS · Class II (moderate risk) · 21 CFR 862.3150 · Clinical Toxicology
100510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Syva Co. 13
- Abbott Laboratories 7
- Roche Diagnostic Systems, Inc. 6
- Princeton BioMeditech Corp. 6
- Microgenics Corp. 4
- Medtox Diagnostics, Inc. 4
- E.I. Dupont DE Nemours & Co., Inc. 3
- Phamatech 3
- ACON Laboratories, Inc. 3
- Diagnostic Reagents, Inc. 3
- Syntron Bioresearch, Inc. 2
- Alfa Scientific Designs, Inc. 2
- OraSure Technologies, Inc. 2
- Randox Laboratories, Ltd. 2
- Roche Diagnostics Corp. 2
- Sun Biomedical Laboratories, Inc. 2
- Lin-Zhi International, Inc. 2
- American Bio Medica Corp. 2
- General Diagnostics 2
- Diagnostic Products Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | Immunalysis Corporation | 10/14/2016SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | Assure Tech. Co., Ltd. | 06/04/2015SE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…DIS · Traditional | Healgen Scientific,, LLC | 04/24/2015SE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | Genprime, Inc. | 12/08/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K062165 | Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…DIS · Traditional | Ortho-Clinical Diagnostics | 01/05/2007SE |
| K050024 | One Step Multiple Drugs of Abuse AssaysDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 11/17/2005SE |
| K050593 | Acon Bar II One Step Barbiturates Test Strip & DeviceDIS · Traditional | ACON Laboratories, Inc. | 05/06/2005SE |
| K043211 | Online Dat Barbiturates PlusDIS · Traditional | Roche Diagnostics Corp. | 12/29/2004SE |
| K042975 | Ameditech Immutest Multi-Drug Screen Panel IIDIS · Traditional | Ameditech, Inc. | 12/29/2004SE |
| K041143 | Randox Barbiturate AssayDIS · Traditional | Randox Laboratories, Ltd. | 11/05/2004SE |
| K041712 | 'Rapidtec 4' TestDIS · Traditional | American Bio Medica Corp. | 11/03/2004SE |
| K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)DIS · Traditional | Lin-Zhi International, Inc. | 05/19/2004SE |
| K033334 | Profile -ErDIS · Special | Medtox Diagnostics, Inc. | 11/10/2003SE |
| K032764 | Barbiturate Enzyme Immunoassay, Ca. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit)DIS · Traditional | Lin-Zhi International, Inc. | 11/03/2003SE |
| K023946 | Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…DIS · Traditional | ACON Laboratories, Inc. | 02/05/2003SE |
| K014089 | Visualine II (Also Known AS Sunline) BarituratesDIS · Traditional | Sun Biomedical Laboratories, Inc. | 04/25/2002SE |
| K020136 | Visualine Barbiturates Dipstrip TestDIS · Traditional | Sun Biomedical Laboratories, Inc. | 03/20/2002SE |
| K012996 | BarbituratesDIS · Traditional | Abbott Laboratories | 03/20/2002SE |
| K012824 | Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test DeviceDIS · Traditional | ACON Laboratories, Inc. | 11/09/2001SE |
| K012133 | Livesure Barbiturates Screen TestDIS · Traditional | Pan Probe Biotech, Inc. | 07/20/2001SE |
| K010125 | Instant-View Barbituate Urine Dip Strip TestDIS · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K003647 | Instant-View Barbiturate Urine Cassette TestDIS · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K010934 | Emit II Plus Barbituate Assay, Model 0SR9D0229DIS · Special | Syva Co., Dade Behring, Inc. | 04/20/2001SE |
| K010959 | Verdict -Ii Bar; Verdict -Ii BzoDIS · Special | Medtox Diagnostics, Inc. | 04/13/2001SE |
| K010561 | Verdict -Ii Bar/BzoDIS · Special | Medtox Diagnostics, Inc. | 04/05/2001SE |
| K002331 | Profile-ErDIS · Traditional | Medtox Diagnostics, Inc. | 01/17/2001SE |
| K001976 | STC Barbiturates Intercept Micro-Plate Eia, Model 1108IDIS · Traditional | OraSure Technologies, Inc. | 12/06/2000SE |
| K002337 | Branan Medical Corporation Monitect Barbiturates Drug Screen TestDIS · Traditional | Branan Medical Corporation | 11/22/2000SE |
| K000522 | Screeners Barbiturate Test, Drugscreen Dip Barbiturate TestDIS · Traditional | Drug Detection Devices, Ltd. | 04/18/2000SE |
| K992451 | Rapidone- Barbiturate TestDIS · Traditional | American Bio Medica Corp. | 04/03/2000SE |
| K000459 | Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog No. DF 96ADIS · Traditional | Dade Behring, Inc. | 04/03/2000SE |
| K990280 | Bionike Aq Barbiturate TestDIS · Traditional | Bionike, Inc. | 06/28/1999SE |
| K991440 | Roche Cobas Integra Serum BarbituratesDIS · Traditional | Roche Diagnostics Corp. | 06/22/1999SE |
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | Roche Diagnostic Systems, Inc. | 05/03/1999SE |
| K991084 | Accusign DOA3, Doa, Bar/Bzo/Mtd, Biosign DOA3, Biosign Bar/Bzo/MtdDIS · Special | Princeton BioMeditech Corp. | 04/15/1999SE |
| K991082 | Accusign DOA2, Doa, Bar/Bzo, Biosign DOA2, Bar/Bzo, Status DS Bar/Bzo, Syva Rapidtest…DIS · Special | Princeton BioMeditech Corp. | 04/15/1999SE |
| K991076 | Accusign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp, Biosign DOA3, DOA3(BZO/BAR/PCP)…DIS · Special | Princeton BioMeditech Corp. | 04/15/1999SE |
| K991018 | Accusign Bar, Biosign Bar, Status BarDIS · Special | Princeton BioMeditech Corp. | 04/15/1999SE |
| K982745 | Auto-Lyte Barbiturates EiaDIS · Traditional | OraSure Technologies, Inc. | 11/18/1998SE |
| K982152 | Quick Screen Barbiturate Screening Test Models 9020 and 9021, Quick Screen Pro Multi…DIS · Traditional | Phamatech | 09/21/1998SE |
| K982551 | Roche C0BAS Integra Serum Barbiturates Reagent Cassette, Abuscreeb Online Serum…DIS · Traditional | Roche Diagnostic Systems, Inc. | 08/18/1998SE |
| K980349 | Quickpac II One Step Barbiturate TestDIS · Traditional | Syntron Bioresearch, Inc. | 03/03/1998SE |
| K974712 | Quikstrip One Step Barbiturate TestDIS · Traditional | Syntron Bioresearch, Inc. | 02/12/1998SE |
| K973047 | One Step Urine Drug of Abuse Barbiturate TestDIS · Traditional | Drial Consultants, Inc. | 10/02/1997SE |
| K963529 | Verdict BarbituratesDIS · Traditional | Editek, Inc. | 10/30/1996SE |
| K962669 | Accusign Bar-Rapid One-Step Barbiturate AssayDIS · Traditional | Princeton BioMeditech Corp. | 08/15/1996SE |
| K961010 | Accusign Doa 3,ACCUSIGN Doa, Accusign Bar/Bzo/Mtd, Biosign Doa 3, Biosign Bar/Bzo/MtdDIS · Traditional | Princeton BioMeditech Corp. | 06/28/1996SE |
| K960664 | Barbiturate Serum Tox Eia AssayDIS · Traditional | Diagnostic Reagents, Inc. | 05/06/1996SE |
| K955928 | Barbiturate Eia Essay (Modification)DIS · Traditional | Diagnostic Reagents, Inc. | 03/11/1996SE |
| K953021 | Acs PhenobarbitalDIS · Traditional | Ciba Corning Diagnostics Corp. | 12/11/1995SE |
| K951253 | Axsym Barbiturates II UDIS · Traditional | Abbott Laboratories | 05/18/1995SE |
| K950137 | Urine Barbiturates Screen Flex(Tm) Reagent CartridgeDIS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/13/1995SE |
| K935116 | Emit Iic Barbiturate AssayDIS · Traditional | Syva Co. | 02/22/1995SE |
| K944075 | Cx(Tm) Barbiturates(Barb) Reagent for Synchron CX SystDIS · Traditional | Beckman Instruments, Inc. | 12/29/1994SE |
| K945344 | Cedia Dau Barbiturate AssayDIS · Traditional | Microgenics Corp. | 12/28/1994SE |
| K942436 | Cedia Dau Barbiturate AssayDIS · Traditional | Microgenics Corp. | 08/30/1994SE |
| K942404 | Cedia(R) Dau Barbiturate Assay, ModificationDIS · Traditional | Microgenics Corp. | 07/28/1994SE |
| K941489 | Ace Clinical Chemistry SystemDIS · Traditional | Schiapparelli Biosystems, Inc. | 07/18/1994SE |
| K936030 | Cedia Dau Barbiturate AssayDIS · Traditional | Microgenics Corp. | 03/22/1994SE |
| K934376 | STC Diagnostics Auto-Lyte Barbiturates EiaDIS · Traditional | Solarcare, Inc. | 12/07/1993SE |
| K933480 | Microline Screen for BarbituratesDIS · Traditional | Drug Screening Systems, Inc. | 10/29/1993SE |
| K931535 | Emit(R) D.A.U. Barbiturate AssayDIS · Traditional | Syva Co. | 06/15/1993SE |
| K926068 | Emit(R) II Barbiturate AssayDIS · Traditional | Syva Co. | 01/12/1993SE |
| K925491 | Barbiturate Eia TestDIS · Traditional | Diagnostic Reagents, Inc. | 12/30/1992SE |
| K920525 | Biotrack Therapeutic Drug Monitoring Qual. ControlDIS · Traditional | Biotrack, Inc. | 08/05/1992SE |
| K920417 | Il Test Barbiturate, 35289DIS · Traditional | Instrumentation Laboratory CO | 04/24/1992SE |
| K920314 | Txit D.A.U. Barbiturate Assay (Modification)DIS · Traditional | Syntex Corp. | 04/17/1992SE |
| K905057 | Ez-Screen:BarbituratesDIS · Traditional | Environmental Diagnostics, Inc. | 11/28/1990SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | Technicon Instruments Corp. | 09/27/1990SE |
| K902580 | Emit(R) II Barbiturate AssayDIS · Traditional | Syva Co. | 07/19/1990SE |
| K896550 | Tdx(R) Barbiturates II AssayDIS · Traditional | Abbott Laboratories | 12/19/1989SE |
| K890690 | Adx TM BarbituratesDIS · Traditional | Abbott Laboratories | 08/25/1989SE |
| K892650 | TDX Barbiturates SerumDIS · Traditional | Abbott Laboratories | 05/16/1989SE |
| K890884 | Abuscreen FP for BarbituratesDIS · Traditional | Roche Diagnostic Systems, Inc. | 03/09/1989SE |
| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | General Diagnostics | 09/19/1988SE |
| K882611 | Emit Hva Barbiturate AssayDIS · Traditional | Syva Co. | 08/08/1988SE |
| K880012 | Revised Labeling for Adx BarbituratesDIS · Traditional | Abbott Laboratories | 03/01/1988SE |
| K874702 | Revised Labeling for Syva Barbiturate AssaysDIS · Traditional | Syva Co. | 01/05/1988SE |
| K874483 | Revised Labeling for TDX BarbituratesDIS · Traditional | Abbott Laboratories | 11/23/1987SE |
| K874266 | Revised Labeling for Barbiturate Test KitDIS · Traditional | Roche Diagnostic Systems, Inc. | 11/13/1987SE |
| K874210 | Revised Labeling for Abuscreen Eia BarbiturateDIS · Traditional | Roche Diagnostic Systems, Inc. | 11/13/1987SE |
| K873623 | Aca Urine Barbiturates Screen MethodDIS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/20/1987SE |
| K873754 | Labeling Change Barbiturates in UrineDIS · Traditional | Diagnostic Products Corp. | 10/15/1987SE |
| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | General Diagnostics | 03/31/1987SE |
| K870936 | Coat-A-Count Barbiturates TKBA1 and TKBA5DIS · Traditional | Diagnostic Products Corp. | 03/19/1987SE |
| K870378 | Abuscreen (R) Eia BarbiturateDIS · Traditional | Roche Diagnostic Systems, Inc. | 03/16/1987SE |
| K842675 | Emit D.A.U. Barbiturate AssayDIS · Traditional | Syva Co. | 09/26/1984SE |
| K843418 | Emit 700 Barbiturate AssayDIS · Traditional | Syva Co. | 09/14/1984SE |
| K842783 | Aca Barbiturates Screen Analy Test PackDIS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/07/1984SE |
| K840194 | Emit ST Serum Barbiturate AssayDIS · Traditional | Syva Co. | 03/19/1984SE |
| K833577 | Modif. of Emit Urine BarbiturateDIS · Traditional | Syva Co. | 01/26/1984SE |
| K810602 | Emit-St Serum Barbiturate AssayDIS · Traditional | Syva Co. | 04/03/1981SE |
| K802617 | Emit-Stm Barbiturate AssayDIS · Traditional | Syva Co. | 10/31/1980SE |
| K792114 | Emit-Barbiturate AssayDIS · Traditional | Syva Co. | 12/04/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1799-2020 Class II | SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product…The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates… | Beckman Coulter Inc. | 06/12/2019Terminated |
| Z-2789-2018 Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030…GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for… | Guangzhou Wondfo Biotech Co., Ltd. | 05/18/2018Open, Classified |
| Z-2788-2018 Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO…GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for… | Guangzhou Wondfo Biotech Co., Ltd. | 05/18/2018Open, Classified |
| Z-2787-2018 Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S)…GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for… | Guangzhou Wondfo Biotech Co., Ltd. | 05/18/2018Open, Classified |
| Z-0722-2017 Class III | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is…Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect… | OraSure Technologies, Inc. | 11/10/2016Terminated |
| Z-1130-2012 | Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of…Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results… | Alere San Diego | 01/04/2012Terminated |
| Z-0846-2012 | Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500…Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such… | Lin-Zhi International Inc | 09/08/2011Terminated |