# MMI: Immunoassay Method, Troponin Subunit

- Device class: 2; regulation: 21 CFR 862.1215; FDA's rule: 510(k) required
- FDA decisions: 95
- 510(k) review time 2021–2025: median 266 days (middle half 176–361)
- Recalls: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 2
- 2017: 1
- 2018: 4
- 2019: 3
- 2021: 1
- 2022: 1
- 2023: 3
- 2024: 2
- 2025: 4
- 2026: 1

## Most-cited predicates
- 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 (2017), cited by 6
- K973650: Troponin (Trop) Method (1997), cited by 4
- K121214: Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System (2013), cited by 4
- K021814: Accutni and Accutni  Calibrators on the Access Immunoassay Systems, Model #33340, 33345 (2002), cited by 3
- K961500: Elecsys Troponin T (1996), cited by 3
- K981098: Stratus CS Cardiac Troponin I Testpak (1998), cited by 3
- K033487: Stratus CS Acute Care Troponin I Testpak, Model Cctni (2003), cited by 2
- K230648: Access hsTnI (2023), cited by 2
- K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303 (2006), cited by 2
- K053020: TNL-Ultra Assay for the Advia Centaur System (2005), cited by 2

Source page: https://510kreport.com/product-code/MMI
Data by year (CSV): https://510kreport.com/product-code/MMI.csv