# MSW: System, Test, Thyroglobulin

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 267 days (middle half 85–458)
- Recalls: 4 (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)
- 1999: 3
- 2000: 3
- 2002: 1
- 2003: 1
- 2023: 2
- 2024: 2
- 2025: 1

## Most-cited predicates
- K002905: Access Thyroglobulin Reagents on the Access Analyzer (2000), cited by 3
- K220972: Access Thyroglobulin (2023), cited by 2
- K994140: Nichols Chemiluminescence Thyroglobulin, Model 60-4240 (2000), cited by 1
- K241423: Access Thyroglobulin (2024), cited by 1

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