Product code MMI
- Device name
- Immunoassay Method, Troponin Subunit
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1215
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| K243483 | Access hsTnI | Beckman Coulter, Inc. | 2025-08-01 |
| K242870 | Access hsTnI | Beckman Coulter, Inc. | 2025-06-16 |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025-01-03 |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 |
| K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | 2024-03-20 |
| K222881 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-18 |
| K230648 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-04 |
| K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2023-05-04 |
| K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022-05-19 |
| K201441 | Elecsys Troponin T Gen 5 | Roche Diagnostics | 2021-09-21 |
| K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019-09-13 |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-05-17 |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-03-04 |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | 2018-07-19 |
| K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | 2018-07-12 |
| K172787 | Access hsTnl | Beckman Coulter, Inc. | 2018-06-14 |
| K172783 | Access hs Tnl | Beckman Coulter, Inc. | 2018-06-12 |
| 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 | 2017-01-18 |
| K121790 | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | 2013-09-25 |
| K121214 | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | 2013-06-14 |
| K100130 | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 | Mitsubishi Chemical Medience CO | 2011-05-16 |
| K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | Nano-Ditech Corporation | 2010-10-20 |
| K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | Nano-Ditech Corporation | 2010-10-20 |
| K082699 | ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS | Roche Diagnostics | 2009-08-19 |
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 | Siemens Healthcare Diagnostics | 2008-07-03 |
| K063243 | VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 | bioMerieux, Inc. | 2007-12-14 |
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | Fisher Diagnostics | 2007-09-13 |
| K063756 | DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2007-03-19 |
| K062838 | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 | Ortho-Clinical Diagnostics | 2006-12-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10054749003058 | i-STAT hs-TnI cartridge | Abbott Point of Care Inc. | 2025-04-29 |
| 30014613337164 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337928 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337959 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337973 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 00895160002458 | Nano-CheckTM 4 in 1 Test | NANO-DITECH CORPORATION | 2016-10-03 |
| 00893038002814 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00893038002807 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00899722002719 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00899722002740 | Alere Triage® | Alere San Diego, Inc. | 2016-09-26 |
| 00842768004490 | Stratus® CS Acute Care™ CKMB TestPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004506 | Stratus® CS Acute Care™ CKMB CalPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004537 | Stratus® CS Acute Care™ cTNI CalPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004544 | Stratus® CS Acute Care™ cTNI DilPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004605 | Stratus® CS Acute Care™ MYO TestPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768004629 | Stratus® CS Acute Care™ MYO DilPak | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 10743816001331 | LifeSign® MI StatusFirst CK-MB/Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001324 | LifeSign® MI CK-MB/Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 00893038002197 | Alere Triage® | Alere San Diego, Inc. | 2016-09-21 |
| 04015630901234 | Roche CARDIAC Control Troponin T | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630920938 | Elecsys Troponin T | Roche Diagnostics GmbH | 2016-09-20 |
| B103A25CS30021 | Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test | International Point of Care Incorporated | 2016-09-15 |
| B103A10CS30021 | Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test | International Point of Care Incorporated | 2016-09-15 |
| 00895160002083 | Nano-CheckTM AMI 2 in 1 | NANO-DITECH CORPORATION | 2016-09-14 |
| 00895160002090 | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION | 2016-09-14 |
| 00895160002120 | Nano-CheckTM AMI 2 in 1 | NANO-DITECH CORPORATION | 2016-09-14 |
| 00895160002137 | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION | 2016-09-14 |
| 10627966005008 | RAMP® Troponin I TEST KIT; 25 TESTS | Response Biomedical Corp | 2016-09-05 |
| 00380740048525 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740003180 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |