MMI — Immunoassay Method, Troponin Subunit Class II
FDA Device Classification
Classification Details
- Product Code
- MMI
- Device Class
- Class II
- Regulation Number
- 862.1215
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252393 | ortho-clinical diagnostics | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | October 29, 2025 |
| K243483 | beckman coulter | Access hsTnI | August 1, 2025 |
| K242870 | beckman coulter | Access hsTnI | June 16, 2025 |
| K240984 | abbott point of care | i-STAT hs-TnI cartridge with the i-STAT 1 System | January 3, 2025 |
| K241165 | siemens healthcare diagnostics | Atellica® IM High-Sensitivity Troponin I (TnIH) | July 25, 2024 |
| K231974 | phc corporation | PATHFAST®hs-cTnI-II | March 20, 2024 |
| K222881 | beckman coulter | Access hsTnI | December 18, 2023 |
| K230648 | beckman coulter | Access hsTnI | December 4, 2023 |
| K230994 | abbott laboratories diagnostics division | Alinity i STAT High Sensitivity Troponin-I | May 4, 2023 |
| K202525 | abbott laboratories diagnostics division | Alinity i STAT High Sensitivity Troponin-I | May 19, 2022 |
| K201441 | roche diagnostics | Elecsys Troponin T Gen 5 | September 21, 2021 |
| K191595 | abbott laboratories diagnostics division | ARCHITECT STAT High Sensitivity Troponin-I | September 13, 2019 |
| K190675 | siemens healthcare diagnostics | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | May 17, 2019 |
| K182225 | siemens healthcare diagnostics | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | March 4, 2019 |
| K171566 | siemens healthcare diagnostics | Atellica IM High-Sensitivity Troponin I (TNIH) | July 19, 2018 |
| K171274 | siemens healthcare diagnostics | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | July 12, 2018 |
| K172787 | beckman coulter | Access hsTnl | June 14, 2018 |
| K172783 | beckman coulter | Access hs Tnl | June 12, 2018 |
| K162895 | roche diagnostics | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecs | January 18, 2017 |
| K121790 | beckman coulter | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOA | September 25, 2013 |