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.
Recent Cleared Devices (20 of 94)
Showing 20 most recent of 94 cleared devices.
| 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 |
Top Applicants
- Beckman Coulter, Inc. — 10 clearances
- Dade Behring, Inc. — 7 clearances
- Boehringer Mannheim Corp. — 6 clearances
- Siemens Healthcare Diagnostics, Inc. — 5 clearances
- Bayer Corp. — 4 clearances
