Biosite Incorporated
Medical device manufacturer in San Diego, CA.
45510(k) clearances
0PMA approvals
11recalls
Device types
- NBC Test, Natriuretic Peptide 8
- DKZ Enzyme Immunoassay, Amphetamine 7
- JJY Multi-Analyte Controls, All Kinds (Assayed) 6
- DIF Drug Mixture Control Materials 4
- JJX Single (Specified) Analyte Controls… 2
- DJR Enzyme Immunoassay, Methadone 2
- GGN Plasma, Coagulation Control 2
- DAP Fibrinogen And Fibrin Split Products… 2
- MCB Antigen, C. Difficile 1
- MHI Giardia Spp. 1
- DJG Enzyme Immunoassay, Opiates 1
- KHO Fluorometer, For Clinical Use 1
- JJT Enzyme Controls (Assayed And Unassayed) 1
- JHX Fluorometric Method, Cpk Or Isoenzymes 1
- GHH Fibrin Split Products 1
- LDP Colorimetry, Acetaminophen 1
- LFI High Pressure Liquid Chromatography… 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- GGP Test, Qualitative And Quantitative Factor… 1
- GJS Test, Time, Prothrombin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K092987 | INRATIO/INRATIO2 Test StripsGJS · Traditional | 06/11/2010SE |
| K092048 | One Step Eddp (Methadone Metabolite) Test StripDJR · Traditional | 04/19/2010SE |
| K093032 | Triage Total 3 Controls and Calibration Verification SetJJY · Traditional | 11/13/2009SE |
| K080269 | Triage Cardioprofiler and Profiler S.O.B. PanelsNBC · Traditional | 06/06/2008SE |
| K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5JJY · Traditional | 12/07/2007SE |
| K062840 | Triage Protein C Controls and Calibration Verification ControlsGGN · Traditional | 03/01/2007SE |
| K062530 | Triage Protein C TestGGP · Traditional | 01/29/2007SE |
| K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414DIF · Traditional | 07/10/2006SE |
| K060791 | Triage Tox Drug Screen, Model 94400DJR · Traditional | 06/22/2006SE |
| K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200NBC · Traditional | 01/23/2006SE |
| K051787 | Triage BNP Test, Model 98000XRNBC · Traditional | 09/22/2005SE |
| K050799 | Triage(R) D-Dimer Calibration Verification Controls; Triage(R) D-Dimer ControlsGGN · Traditional | 06/29/2005SE |
| K050037 | Triage Tox Drug Screen ControlsDIF · Traditional | 03/22/2005SE |
| K043242 | Triage Tox Drug ScreenLDP · Traditional | 02/28/2005SE |
| K042723 | Trigage Profiler S.O.B. Panel, Model 97300DAP · Traditional | 12/07/2004SE |
| K042890 | Triage D-Dimer Test, Model 98100GHH · Traditional | 11/29/2004SE |
| K040459 | Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsJJY · Traditional | 07/06/2004SE |
| K040437 | Triage Profiler S.O.B. PanelDAP · Traditional | 06/25/2004SE |
| K032235 | Modification to Triage B-Type Natriuretic Peptide (BNP) TestNBC · Traditional | 01/28/2004SE |
| K033383 | Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200NBC · Traditional | 12/23/2003SE |
| K030286 | Triage Cardio Profiler/Triage Cardiac PanelNBC · Special | 02/21/2003SE |
| K030089 | Triage Cardiac Controls; Triage Cardio Profiler ControlsJJY · Traditional | 01/23/2003SE |
| K030088 | Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration…JJY · Traditional | 01/17/2003SE |
| K021317 | Triage B-Type Natriuretic Peptide (BNP) TestNBC · Traditional | 07/01/2002SE |
| K014247 | Triage Drugs of Abuse Panel Plus PPX, Model Catalog 92002DKZ · Traditional | 06/03/2002SE |
| K012745 | Triage Tox Drug Screen, Catalog #94000DKZ · Traditional | 01/10/2002SE |
| K013002 | Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002DIF · Traditional | 10/03/2001SE |
| K012999 | Triage Tox Drug Screen Controls, Catalog #94001DIF · Traditional | 10/03/2001SE |
| K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000NBC · Traditional | 03/16/2001SE |
| K000231 | Triage BNP Calibration Verification ControlsJJX · Traditional | 03/02/2000SE |
| K000230 | Triage B-Type Natriuretic Peptide (BNP) ControlsJJX · Traditional | 02/29/2000SE |
| K982245 | Triage,Parasite Panel, Triage Cryptosporidium and Entamoeba Histolytica, Triage…MHI · Traditional | 10/06/1998SE |
| K974881 | Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin aMCB · Traditional | 03/20/1998SE |
| K973547 | Triage StatmeterKHO · Traditional | 01/13/1998SE |
| K974827 | Triage(R) Cardiac Panel Calibration Verification Controls, Triag (R) Myoglobin…JJY · Traditional | 01/08/1998SE |
| K974461 | Triage Cardiac Controls, Triage Troponin-I Control, Triage Ck-Mb Control, Triage…JJT · Traditional | 12/10/1997SE |
| K973784 | Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug…DKZ · Traditional | 12/03/1997SE |
| K973126 | Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage…JHX · Traditional | 10/06/1997SE |
| K955934 | Triage Panel for Drugs of Abuse Model 9500/93000DKZ · Traditional | 02/16/1996SE |
| K955935 | Triage Panel for Drugs of Abuse/Tricyclic AntidepressantsDKZ · Traditional | 02/15/1996SE |
| K934340 | Biosite Diagnostics - Triage Panel for Drugs of Abuse Plus Tricyclic AntidepressantsLFI · Traditional | 12/02/1994SE |
| K931598 | Biosite Triage Panel for Drugs of ABUSE(50NG/ML)LDJ · Traditional | 05/12/1993SE |
| K924476 | The Triage IIDKZ · Traditional | 01/22/1993SE |
| K914146 | Biosite Diagnostics-Triage Panel for Drugs AbuseDKZ · Traditional | 10/11/1991SE |
| K902924 | Biosite Diagnostics Opiate Screening TestDJG · Traditional | 09/14/1990SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1391-2009 | Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in…The recall was initiated because the use of the affected lot may lead to reporting falsely low values for… | 04/27/2009Terminated |
| 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… | 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… | 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… | 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… | 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… | 04/27/2009Terminated |
| Z-1790-2010 | Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five…Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in… | 02/06/2009Terminated |
| Z-1789-2010 | Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. Intended use:…Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in… | 02/06/2009Terminated |
| Z-1788-2010 | Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended use:…Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in… | 02/06/2009Terminated |
| 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… | 11/06/2008Terminated |
| Z-1352-2008 | Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE…False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual… | 12/04/2007Terminated |