MMI — Immunoassay Method, Troponin Subunit Class II
FDA product code MMI covers "Immunoassay Method, Troponin Subunit", a Class II medical device regulated under 21 CFR 862.1215. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253051 | abbott point of care | i-STAT hs-TnI cartridge with the i-STAT Alinity System | June 11, 2026 |
| 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 |