# JLW: Radioimmunoassay, Thyroid-Stimulating Hormone

- Device class: 2; regulation: 21 CFR 862.1690; FDA's rule: 510(k) required
- FDA decisions: 242
- 510(k) review time 2021–2025: median 196 days (middle half 192–209)
- Recalls: 19 (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)
- 2014: 1
- 2015: 3
- 2016: 3
- 2017: 4
- 2019: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K961491: Elecsys TSH Assay (1996), cited by 5
- K083844: Advia Centaur TSH3-Ultra Method (2009), cited by 4
- K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (2015), cited by 3
- K042281: Modification to Access Hypersensitive HTSH Assay (2004), cited by 3
- K081543: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600 Integrated System (2008), cited by 2
- K954825: Access Hypersensitive TSH Reagents on the Access Immunoassay Analyzer (1995), cited by 2
- K060090: Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge (2006), cited by 2
- K081074: Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691 (2008), cited by 2
- K925637: Access HTSH Assay (1993), cited by 2
- K150403: ADVIA Centaur TSH3-Ultra (2015), cited by 2

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