MMI · Immunoassay Method, Troponin Subunit
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | MMI |
|---|---|
| Device Name | Immunoassay Method, Troponin Subunit |
| Regulation | 21 CFR 862.1215 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Classification Rationale
Class II.
Cleared Devices (94)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | Oct 29, 2025 | SESE |
| K243483 | Access hsTnI | Beckman Coulter, Inc. | Aug 1, 2025 | SESE |
| K242870 | Access hsTnI | Beckman Coulter, Inc. | Jun 16, 2025 | SESE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Jan 3, 2025 | SESE |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | Jul 25, 2024 | SESE |
| K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | Mar 20, 2024 | SESE |
| K222881 | Access hsTnI | Beckman Coulter, Inc. | Dec 18, 2023 | SESE |
| K230648 | Access hsTnI | Beckman Coulter, Inc. | Dec 4, 2023 | SESE |
| K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | May 4, 2023 | SESE |
| K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | May 19, 2022 | SESE |
| K201441 | Elecsys Troponin T Gen 5 | Roche Diagnostics | Sep 21, 2021 | SESE |
| K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | Sep 13, 2019 | SESE |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | May 17, 2019 | SESE |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | Mar 4, 2019 | SESE |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | Jul 19, 2018 | SESE |
| K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | Jul 12, 2018 | SESE |
| K172787 | Access hsTnl | Beckman Coulter, Inc. | Jun 14, 2018 | SESE |
| K172783 | Access hs Tnl | Beckman Coulter, Inc. | Jun 12, 2018 | SESE |
| K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 | Roche Diagnostics | Jan 18, 2017 | SESE |
| K121790 | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | Sep 25, 2013 | SESE |
| K121214 | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | Jun 14, 2013 | SESE |
| K100130 | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 | Mitsubishi Chemical Medience CO | May 16, 2011 | SESE |
| K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | Nano-Ditech Corporation | Oct 20, 2010 | SESE |
| K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | Nano-Ditech Corporation | Oct 20, 2010 | SESE |
| K082699 | ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS | Roche Diagnostics | Aug 19, 2009 | SESE |
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 | Siemens Healthcare Diagnostics | Jul 3, 2008 | SESE |
| K063243 | VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 | bioMerieux, Inc. | Dec 14, 2007 | SESE |
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | Fisher Diagnostics | Sep 13, 2007 | SESE |
| K063756 | DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 19, 2007 | SESE |
| K062838 | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 | Ortho-Clinical Diagnostics | Dec 19, 2006 | SESE |
| K060875 | ABBOTT AXSYM TROPONIN-I ADV | Abbott Laboratories | Jun 14, 2006 | SESE |
| K053577 | DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT | Dade Behring, Inc. | Apr 14, 2006 | SESE |
| K050975 | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN | Nano-Ditech Co. | Mar 2, 2006 | SESE |
| K053020 | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Healthcare, LLC | Dec 30, 2005 | SESE |
| K052503 | TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM | Bayer Healthcare, LLC | Dec 14, 2005 | SESE |
| K051925 | CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN | Access Bio Incorporate | Nov 29, 2005 | SESE |
| K050644 | VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT | Vancouver Biotech , Ltd. | Aug 17, 2005 | SESE |
| K051752 | ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) | Roche Diagnostics | Jul 11, 2005 | SESE |
| K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 | Biocheck, Inc. | Dec 17, 2004 | SESE |
| K042227 | INSTANT-VIEW TROPONIN I TEST | Alfa Scientific Designs, Inc. | Nov 19, 2004 | SESE |
| K041811 | ABBOTT AXSYM TROPONIN-I ADV | Abbott Laboratories | Sep 10, 2004 | SESE |
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | Fisher Diagnostics | Aug 12, 2004 | SESE |
| K040733 | ELECSYS TROPONIN T STAT TEST | Roche Diagnostics Corp. | May 17, 2004 | SESE |
| K033745 | RAMP TROPONIN I ASSAY | Response Biomedical Corp. | May 17, 2004 | SESE |
| K033487 | STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI | Dade Behring, Inc. | Dec 24, 2003 | SESE |
| K031031 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | Sep 29, 2003 | SESE |
| K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST | I-Stat Corporation | Sep 2, 2003 | SESE |
| K030950 | VIDAS TROPONIN I (TNI), MODEL 30 445 | bioMerieux, Inc. | Jun 16, 2003 | SESE |
| K023505 | VBL SERUM TROPONIN I TEST, MODEL 1001 | Vancouver Biotech , Ltd. | Mar 31, 2003 | SESE |
| K030057 | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST | Spectral Diagnostics, Inc. | Mar 19, 2003 | SESE |
| K024193 | MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS | Ortho-Clinical Diagnostics | Feb 21, 2003 | SESE |
| K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST | Princeton BioMeditech Corp. | Oct 8, 2002 | SESE |
| K021814 | ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 | Beckman Coulter, Inc. | Sep 27, 2002 | SESE |
| K020950 | SPECTRAL'S 2 IN 1 (TNI-MYO) | Spectral Diagnostics, Inc. | May 24, 2002 | SESE |
| K020662 | MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS | Ortho-Clinical Diagnostics | Apr 12, 2002 | SESE |
| K014105 | SPECTRAL'S TROPONIN I | Spectral Diagnostics, Inc. | Feb 1, 2002 | SESE |
| K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | Biocheck, Inc. | Jan 8, 2002 | SESE |
| K014024 | MODIFICATION TO ALPHA DX SYSTEM | First Medical, Inc. | Dec 18, 2001 | SESE |
| K012820 | AIA-PACK CTNI 2ND-GEN ASSAY | Tosoh Medics, Inc. | Dec 14, 2001 | SESE |
| K010429 | ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 | Beckman Coulter, Inc. | Jun 5, 2001 | SESE |
| K010313 | DIMENSION CTNI FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Apr 20, 2001 | SESE |
| K010201 | BAYER ADVIA IMS SYSTEM | Bayer Corp. | Mar 29, 2001 | SESE |
| K010562 | ALPHA DX SYSTEM | First Medical, Inc. | Mar 13, 2001 | SESE |
| K000784 | THE CARDIAC READER SYSTEM | Roche Diagnostics Corp. | May 18, 2000 | SESE |
| K993353 | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | Dec 6, 1999 | SESE |
| K993309 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY | Bayer Corp. | Dec 6, 1999 | SESE |
| K992366 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | Oct 8, 1999 | SESE |
| K992127 | CARDIOQUANT TROPONIN I TEST | Spectral Diagnostics, Inc. | Oct 4, 1999 | SESE |
| K991177 | OPUS TROPONIN I (CTN) TEST MODULES | Dade Behring, Inc. | Jul 1, 1999 | SESE |
| K991795 | IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 | Diagnostic Products Corp. | Jun 9, 1999 | SESE |
| K984359 | AIA-PACK TROPONIN I ASSAY | Tosoh Medics, Inc. | Dec 23, 1998 | SESE |
| K984093 | STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK | Dade Behring, Inc. | Dec 14, 1998 | SESE |
| K984105 | ELECSYS TROPONIN T STAT TEST | Boehringer Mannheim Corp. | Dec 8, 1998 | SESE |
| K983972 | IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 | Diagnostic Products Corp. | Dec 7, 1998 | SESE |
| K981882 | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST | Princeton BioMeditech Corp. | Jul 6, 1998 | SESE |
| K981098 | STRATUS CS CARDIAC TROPONIN I TESTPAK | Dade Behring, Inc. | Apr 27, 1998 | SESE |
| K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) | Chiron Diagnostics Corp. | Mar 3, 1998 | SESE |
| K974839 | 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 | First Medical, Inc. | Feb 4, 1998 | SESE |
| K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Radiometer America, Inc. | Jan 16, 1998 | SESE |
| K973616 | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | Dec 5, 1997 | SESE |
| K974103 | ABBOTT AXSYM TROPONIN-I | Abbott Laboratories | Nov 25, 1997 | SESE |
| K974075 | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | Nov 10, 1997 | SESE |
| K973650 | TROPONIN (TROP) METHOD | Dade Chemistry Systems, Inc. | Oct 20, 1997 | SESE |
| K972094 | TARGET CARDIAC TROPONIN I TEST | Texas Immunology, Inc. | Jul 23, 1997 | SESE |
| K964862 | TROPONIN-I TEST SYSTEM | Dade Intl., Inc. | Feb 10, 1997 | SESE |
| K964372 | CARDIAC T TROPONIN T RAPID ASSAY | Boehringer Mannheim Corp. | Feb 10, 1997 | SESE |
| K963934 | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 | Bio-Rad Laboratories, Inc. | Dec 16, 1996 | SESE |
| K963513 | CARDIAC STATUS TROPONIN I | Princeton BioMeditech Corp. | Nov 7, 1996 | SESE |
| K961500 | ELECSYS TROPONIN T | Boehringer Mannheim Corp. | Jun 11, 1996 | SESE |
| K955868 | BOEHRINGER MANNHEIM CARDIAC T TROPNIN T | Boehringer Mannheim Corp. | Feb 14, 1996 | SESE |
| K955284 | OPUS TROPONIN I | Behring Diagnostics, Inc. | Jan 25, 1996 | SESE |
| K952478 | BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY | Boehringer Mannheim Corp. | Nov 9, 1995 | SESE |
| K951890 | STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS | Dade Intl., Inc. | Jul 13, 1995 | SESE |
| K924392 | CARDIAC T ELISA TROPONIN-T | Boehringer Mannheim Corp. | Apr 26, 1994 | SESE |
Top Applicants
- Beckman Coulter, Inc. — 10 clearances
- Dade Behring, Inc. — 7 clearances
- Boehringer Mannheim Corp. — 6 clearances
- Siemens Healthcare Diagnostics, Inc. — 5 clearances
- Spectral Diagnostics, Inc. — 4 clearances
