Company ยท US
Biosite Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2010. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 13 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 9 |
| NBC | Test, Natriuretic Peptide | 9 |
| DIF | Drug Mixture Control Materials | 4 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 |
| GGN | Plasma, Coagulation Control | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| MCB | Antigen, C. Difficile | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| GHH | Fibrin Split Products | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
| LDP | Colorimetry, Acetaminophen | 1 |
| LFI | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | 1 |
| MHI | Giardia Spp. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 2010 | K092987 | INRATIO/INRATIO2 TEST STRIPS Biosite Incorporated | GJS |
| Apr 19, 2010 | K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP Biosite Incorporated | DJR |
| Nov 13, 2009 | K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET Biosite Incorporated | JJY |
| Jun 6, 2008 | K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS Biosite Incorporated | NBC |
| Dec 7, 2007 | K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 Biosite Incorporated | JJY |
| Mar 1, 2007 | K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS Biosite Incorporated | GGN |
| Jan 29, 2007 | K062530 | TRIAGE PROTEIN C TEST Biosite Incorporated | GGP |
| Jul 10, 2006 | K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 Biosite Incorporated | DIF |
| Jun 22, 2006 | K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 Biosite Incorporated | DJR |
| Jan 23, 2006 | K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 Biosite Incorporated | NBC |
| Sep 22, 2005 | K051787 | TRIAGE BNP TEST, MODEL 98000XR Biosite Incorporated | NBC |
| Jun 29, 2005 | K050799 | TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS Biosite Incorporated | GGN |
| Mar 22, 2005 | K050037 | TRIAGE TOX DRUG SCREEN CONTROLS Biosite Incorporated | DIF |
| Feb 28, 2005 | K043242 | TRIAGE TOX DRUG SCREEN Biosite Incorporated | LDP |
| Dec 7, 2004 | K042723 | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 Biosite Incorporated | DAP |
| Nov 29, 2004 | K042890 | TRIAGE D-DIMER TEST, MODEL 98100 Biosite Incorporated | GHH |
| Jul 6, 2004 | K040459 | TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS Biosite Incorporated | JJY |
| Jun 25, 2004 | K040437 | TRIAGE PROFILER S.O.B. PANEL Biosite Incorporated | DAP |
| Jan 28, 2004 | K032235 | MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST Biosite Incorporated | NBC |
| Dec 23, 2003 | K033383 | TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 Biosite Incorporated | NBC |
| Feb 21, 2003 | K030286 | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL Biosite Incorporated | NBC |
| Jan 23, 2003 | K030089 | TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS Biosite Incorporated | JJY |
| Jan 17, 2003 | K030088 | TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS Biosite Incorporated | JJY |
| Jul 1, 2002 | K021317 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST Biosite Incorporated | NBC |
| Jun 3, 2002 | K014247 | TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 Biosite Incorporated | DKZ |
| Jan 10, 2002 | K012745 | TRIAGE TOX DRUG SCREEN, CATALOG #94000 Biosite Incorporated | DKZ |
| Oct 3, 2001 | K013002 | TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 Biosite Incorporated | DIF |
| Oct 3, 2001 | K012999 | TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 Biosite Incorporated | DIF |
| Mar 16, 2001 | K010266 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 Biosite Incorporated | NBC |
| Nov 20, 2000 | DEN000010 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST Biosite Incorporated | NBC |
| Mar 2, 2000 | K000231 | TRIAGE BNP CALIBRATION VERIFICATION CONTROLS Biosite Incorporated | JJX |
| Feb 29, 2000 | K000230 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS Biosite Incorporated | JJX |
| Oct 6, 1998 | K982245 | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA Biosite Incorporated | MHI |
| Mar 20, 1998 | K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A Biosite Incorporated | MCB |
| Jan 13, 1998 | K973547 | TRIAGE STATMETER Biosite Incorporated | KHO |
| Jan 8, 1998 | K974827 | TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE Biosite Incorporated | JJY |
| Dec 10, 1997 | K974461 | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL Biosite Incorporated | JJT |
| Dec 3, 1997 | K973784 | TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS Biosite Incorporated | DKZ |
| Oct 6, 1997 | K973126 | TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I Biosite Incorporated | JHX |
| Feb 16, 1996 | K955934 | TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 Biosite Incorporated | DKZ |
| Feb 15, 1996 | K955935 | TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS Biosite Incorporated | DKZ |
| Dec 2, 1994 | K934340 | BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS Biosite Incorporated | LFI |
| May 12, 1993 | K931598 | BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML) Biosite Incorporated | LDJ |
| Jan 22, 1993 | K924476 | THE TRIAGE II Biosite Incorporated | DKZ |
| Oct 11, 1991 | K914146 | BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE Biosite Incorporated | DKZ |
| Sep 14, 1990 | K902924 | BIOSITE DIAGNOSTICS OPIATE SCREENING TEST Biosite Incorporated | DJG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2010 | Biosite Inc Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C.
Intended use: Materials used with the Triage Profiler S.O. Terminated |
JJY | K072892 |
| Jun 11, 2010 | Biosite Inc Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C.
Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Terminated |
JJY | K072892 |
| Jun 11, 2010 | Biosite Inc Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C.
Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Tes Terminated |
JJY | K072892 |
| Oct 6, 2009 | Biosite Inc Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| May 8, 2009 | Biosite Inc Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box.
Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determi Terminated |
MMI | K030286 |
| Mar 17, 2009 | Biosite Inc Triage Drugs of Abuse Panel, Model Number: 95000.
Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine. Terminated |
DKZ | K973784 |
| Mar 27, 2008 | Biosite Inc Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121 Terminated |
MCB | K974881 |