Panels › Clinical Chemistry › Product code MMI · Class 2
Immunoassay Method, Troponin Subunit
Regulation 862.1215
1510(k)s in 12 months (95 all time)
0recalls in 12 months (56 all time)
54recalls that name a 510(k)
Top companies in MMI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 2026 | K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System Abbott Point of Care, Inc. | MMI |
| Oct 29, 2025 | K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack Ortho-Clinical Diagnostics, Inc. | MMI |
| Aug 1, 2025 | K243483 | Access hsTnI Beckman Coulter, Inc. | MMI |
| Jun 16, 2025 | K242870 | Access hsTnI Beckman Coulter, Inc. | MMI |
| Jan 3, 2025 | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | MMI |
| Jul 25, 2024 | K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) Siemens Healthcare Diagnostics, Inc. | MMI |
| Mar 20, 2024 | K231974 | PATHFAST®hs-cTnI-II Phc Corporation, JP | MMI |
| Dec 18, 2023 | K222881 | Access hsTnI Beckman Coulter, Inc. | MMI |
| Dec 4, 2023 | K230648 | Access hsTnI Beckman Coulter, Inc. | MMI |
| May 4, 2023 | K230994 | Alinity i STAT High Sensitivity Troponin-I Abbott Laboratories Diagnostics Division | MMI |
| May 19, 2022 | K202525 | Alinity i STAT High Sensitivity Troponin-I Abbott Laboratories Diagnostics Division | MMI |
| Sep 21, 2021 | K201441 | Elecsys Troponin T Gen 5 Roche Diagnostics | MMI |
| Sep 13, 2019 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I Abbott Laboratories Diagnostics Division | MMI |
| May 17, 2019 | K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc. | MMI |
| Mar 4, 2019 | K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc. | MMI |
| Jul 19, 2018 | K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) Siemens Healthcare Diagnostics, Inc. | MMI |
| Jul 12, 2018 | K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) Siemens Healthcare Diagnostics, Inc. | MMI |
| Jun 14, 2018 | K172787 | Access hsTnl Beckman Coulter, Inc. | MMI |
| Jun 12, 2018 | K172783 | Access hs Tnl Beckman Coulter, Inc. | MMI |
| Jan 18, 2017 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Tropon Roche Diagnostics | MMI |
| Sep 25, 2013 | K121790 | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM Beckman Coulter, Inc. | MMI |
| Jun 14, 2013 | K121214 | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM Beckman Coulter, Inc. | MMI |
| May 16, 2011 | K100130 | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 Mitsubishi Chemical Medience CO | MMI |
| Oct 20, 2010 | K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN Nano-Ditech Corporation | MMI |
| Oct 20, 2010 | K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST Nano-Ditech Corporation | MMI |
| Aug 19, 2009 | K082699 | ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS Roche Diagnostics | MMI |
| Jul 3, 2008 | K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 Siemens Healthcare Diagnostics | MMI |
| Dec 14, 2007 | K063243 | VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 bioMerieux, Inc. | MMI |
| Sep 13, 2007 | K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN Fisher Diagnostics | MMI |
| Mar 19, 2007 | K063756 | DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE Dade Behring, Inc. | MMI |
| Dec 19, 2006 | K062838 | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 Ortho-Clinical Diagnostics | MMI |
| Jun 14, 2006 | K060875 | ABBOTT AXSYM TROPONIN-I ADV Abbott Laboratories | MMI |
| Apr 14, 2006 | K053577 | DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT Dade Behring, Inc. | MMI |
| Mar 2, 2006 | K050975 | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN Nano-Ditech Co. | MMI |
| Dec 30, 2005 | K053020 | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Healthcare, LLC | MMI |
| Dec 14, 2005 | K052503 | TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM Bayer Healthcare, LLC | MMI |
| Nov 29, 2005 | K051925 | CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN Access Bio Incorporate | MMI |
| Aug 17, 2005 | K050644 | VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT Vancouver Biotech , Ltd., CA | MMI |
| Jul 11, 2005 | K051752 | ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) Roche Diagnostics | MMI |
| Dec 17, 2004 | K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 Biocheck, Inc. | MMI |
| Nov 19, 2004 | K042227 | INSTANT-VIEW TROPONIN I TEST Alfa Scientific Designs, Inc. | MMI |
| Sep 10, 2004 | K041811 | ABBOTT AXSYM TROPONIN-I ADV Abbott Laboratories | MMI |
| Aug 12, 2004 | K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY Fisher Diagnostics | MMI |
| May 17, 2004 | K040733 | ELECSYS TROPONIN T STAT TEST Roche Diagnostics Corp. | MMI |
| May 17, 2004 | K033745 | RAMP TROPONIN I ASSAY Response Biomedical Corp., CA | MMI |
| Dec 24, 2003 | K033487 | STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI Dade Behring, Inc. | MMI |
| Sep 29, 2003 | K031031 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc. | MMI |
| Sep 2, 2003 | K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST I-Stat Corporation | MMI |
| Jun 16, 2003 | K030950 | VIDAS TROPONIN I (TNI), MODEL 30 445 bioMerieux, Inc. | MMI |
| Mar 31, 2003 | K023505 | VBL SERUM TROPONIN I TEST, MODEL 1001 Vancouver Biotech , Ltd. | MMI |
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