# JNL: Immunochemical, Thyroglobulin Autoantibody

- Device class: 2; regulation: 21 CFR 866.5870; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 172 days (middle half 128–217)
- Recalls: 3 (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)
- 1993: 1
- 1994: 2
- 1995: 6
- 1996: 2
- 1997: 1
- 2006: 1
- 2007: 1
- 2011: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K112933: Access Thyroglobulin Anitbody (2011), cited by 2
- K905486: Immunowell Tpo (Microsome) Test (1991), cited by 1
- K062516: Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators) (2006), cited by 1

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