FDA 510(k) Applications for Medical Device Product Code "MMI"
(Immunoassay Method, Troponin Subunit)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K974103 | ABBOTT LABORATORIES | ABBOTT AXSYM TROPONIN-I | 11/25/1997 |
| K060875 | ABBOTT LABORATORIES | ABBOTT AXSYM TROPONIN-I ADV | 06/14/2006 |
| K041811 | ABBOTT LABORATORIES | ABBOTT AXSYM TROPONIN-I ADV | 09/10/2004 |
| K230994 | Abbott Laboratories Diagnostics Division | Alinity i STAT High Sensitivity Troponin-I | 05/04/2023 |
| K202525 | Abbott Laboratories Diagnostics Division | Alinity i STAT High Sensitivity Troponin-I | 05/19/2022 |
| K191595 | Abbott Laboratories Diagnostics Division | ARCHITECT STAT High Sensitivity Troponin-I | 09/13/2019 |
| K051925 | ACCESS BIO INCORPORATE | CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN | 11/29/2005 |
| K042227 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW TROPONIN I TEST | 11/19/2004 |
| K010201 | BAYER CORP. | BAYER ADVIA IMS SYSTEM | 03/29/2001 |
| K993309 | BAYER CORP. | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY | 12/06/1999 |
| K973616 | BAYER CORP. | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | 12/05/1997 |
| K993353 | BAYER CORP. | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) | 12/06/1999 |
| K053020 | BAYER HEALTHCARE, LLC | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM | 12/30/2005 |
| K052503 | BAYER HEALTHCARE, LLC | TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM | 12/14/2005 |
| K121790 | BECKMAN COULTER, INC. | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM | 09/25/2013 |
| K121214 | BECKMAN COULTER, INC. | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM | 06/14/2013 |
| K172783 | Beckman Coulter, Inc. | Access hs Tnl | 06/12/2018 |
| K172787 | Beckman Coulter, Inc. | Access hsTnl | 06/14/2018 |
| K021814 | BECKMAN COULTER, INC. | ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 | 09/27/2002 |
| K010429 | BECKMAN COULTER, INC. | ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 | 06/05/2001 |
| K974075 | BECKMAN INSTRUMENTS, INC. | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | 11/10/1997 |
| K955284 | BEHRING DIAGNOSTICS, INC. | OPUS TROPONIN I | 01/25/1996 |
| K963934 | BIO-RAD LABORATORIES, INC. | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 | 12/16/1996 |
| K041619 | BIOCHECK, INC. | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 | 12/17/2004 |
| K013062 | BIOCHECK, INC. | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | 01/08/2002 |
| K030950 | BIOMERIEUX, INC. | VIDAS TROPONIN I (TNI), MODEL 30 445 | 06/16/2003 |
| K063243 | BIOMERIEUX, INC. | VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 | 12/14/2007 |
| K955868 | BOEHRINGER MANNHEIM CORP. | BOEHRINGER MANNHEIM CARDIAC T TROPNIN T | 02/14/1996 |
| K964372 | BOEHRINGER MANNHEIM CORP. | CARDIAC T TROPONIN T RAPID ASSAY | 02/10/1997 |
| K961500 | BOEHRINGER MANNHEIM CORP. | ELECSYS TROPONIN T | 06/11/1996 |
| K984105 | BOEHRINGER MANNHEIM CORP. | ELECSYS TROPONIN T STAT TEST | 12/08/1998 |
| K980528 | CHIRON DIAGNOSTICS CORP. | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) | 03/03/1998 |
| K010313 | DADE BEHRING, INC. | DIMENSION CTNI FLEX REAGENT CARTRIDGE | 04/20/2001 |
| K053577 | DADE BEHRING, INC. | DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT | 04/14/2006 |
| K063756 | DADE BEHRING, INC. | DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE | 03/19/2007 |
| K991177 | DADE BEHRING, INC. | OPUS TROPONIN I (CTN) TEST MODULES | 07/01/1999 |
| K984093 | DADE BEHRING, INC. | STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK | 12/14/1998 |
| K033487 | DADE BEHRING, INC. | STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI | 12/24/2003 |
| K981098 | DADE BEHRING, INC. | STRATUS CS CARDIAC TROPONIN I TESTPAK | 04/27/1998 |
| K973650 | DADE CHEMISTRY SYSTEMS, INC. | TROPONIN (TROP) METHOD | 10/20/1997 |
| K964862 | DADE INTL., INC. | TROPONIN-I TEST SYSTEM | 02/10/1997 |
| K983972 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 | 12/07/1998 |
| K991795 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 | 06/09/1999 |
| K974839 | FIRST MEDICAL, INC. | ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT | 02/04/1998 |
| K010562 | FIRST MEDICAL, INC. | ALPHA DX SYSTEM | 03/13/2001 |
| K014024 | FIRST MEDICAL, INC. | MODIFICATION TO ALPHA DX SYSTEM | 12/18/2001 |
| K070640 | FISHER DIAGNOSTICS | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | 09/13/2007 |
| K041192 | FISHER DIAGNOSTICS | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | 08/12/2004 |
| K031739 | I-STAT CORPORATION | I-STAT CARDIAC TROPONIN (CTNI) TEST | 09/02/2003 |
| K100130 | MITSUBISHI CHEMICAL MEDIENCE CO | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 | 05/16/2011 |
| K050975 | NANO-DITECH CO. | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN | 03/02/2006 |
| K102441 | NANO-DITECH CORPORATION | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | 10/20/2010 |
| K102131 | NANO-DITECH CORPORATION | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | 10/20/2010 |
| K024193 | ORTHO-CLINICAL DIAGNOSTICS | MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS | 02/21/2003 |
| K020662 | ORTHO-CLINICAL DIAGNOSTICS | MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS | 04/12/2002 |
| K062838 | ORTHO-CLINICAL DIAGNOSTICS | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 | 12/19/2006 |
| K992366 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK | 10/08/1999 |
| K031031 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS | 09/29/2003 |
| K981882 | PRINCETON BIOMEDITECH CORP. | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST | 07/06/1998 |
| K963513 | PRINCETON BIOMEDITECH CORP. | CARDIAC STATUS TROPONIN I | 11/07/1996 |
| K022946 | PRINCETON BIOMEDITECH CORP. | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST | 10/08/2002 |
| K974818 | RADIOMETER AMERICA, INC. | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | 01/16/1998 |
| K033745 | RESPONSE BIOMEDICAL CORP. | RAMP TROPONIN I ASSAY | 05/17/2004 |
| K082699 | Roche Diagnostics | ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS | 08/19/2009 |
| K201441 | Roche Diagnostics | Elecsys Troponin T Gen 5 | 09/21/2021 |
| K162895 | Roche Diagnostics | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 | 01/18/2017 |
| K051752 | Roche Diagnostics | ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) | 07/11/2005 |
| K040733 | ROCHE DIAGNOSTICS CORP. | ELECSYS TROPONIN T STAT TEST | 05/17/2004 |
| K000784 | ROCHE DIAGNOSTICS CORP. | THE CARDIAC READER SYSTEM | 05/18/2000 |
| K081643 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 | 07/03/2008 |
| K171274 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | 07/12/2018 |
| K171566 | Siemens Healthcare Diagnostics Inc. | Atellica IM High-Sensitivity Troponin I (TNIH) | 07/19/2018 |
| K190675 | Siemens Healthcare Diagnostics, Inc. | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | 05/17/2019 |
| K182225 | Siemens Healthcare Diagnostics, Inc. | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | 03/04/2019 |
| K992127 | SPECTRAL DIAGNOSTICS, INC. | CARDIOQUANT TROPONIN I TEST | 10/04/1999 |
| K030057 | SPECTRAL DIAGNOSTICS, INC. | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST | 03/19/2003 |
| K020950 | SPECTRAL DIAGNOSTICS, INC. | SPECTRAL'S 2 IN 1 (TNI-MYO) | 05/24/2002 |
| K014105 | SPECTRAL DIAGNOSTICS, INC. | SPECTRAL'S TROPONIN I | 02/01/2002 |
| K972094 | TEXAS IMMUNOLOGY, INC. | TARGET CARDIAC TROPONIN I TEST | 07/23/1997 |
| K012820 | TOSOH MEDICS, INC. | AIA-PACK CTNI 2ND-GEN ASSAY | 12/14/2001 |
| K984359 | TOSOH MEDICS, INC. | AIA-PACK TROPONIN I ASSAY | 12/23/1998 |
| K050644 | VANCOUVER BIOTECH LTD. | VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT | 08/17/2005 |
| K023505 | VANCOUVER BIOTECH LTD. | VBL SERUM TROPONIN I TEST, MODEL 1001 | 03/31/2003 |
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