# JZO: System, Test, Thyroid Autoantibody

- Device class: 2; regulation: 21 CFR 866.5870; FDA's rule: 510(k) required
- FDA decisions: 92
- 510(k) review time 2021–2025: median 322 days (middle half 239–460)
- Recalls: 2 (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)
- 2005: 1
- 2006: 5
- 2008: 2
- 2009: 2
- 2010: 1
- 2016: 2
- 2020: 1
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K080092: Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab (2008), cited by 3
- K972190: Thyroglobulin Assay System (1997), cited by 2
- K950090: Orgentec Anti-Tpo Pia (Pin Immuno Assay) (1995), cited by 2
- K980206: Immulite Anti-TG AB (1998), cited by 1
- K981930: Unicap Thyroid Peroxidase Igg (1998), cited by 1
- K992790: Brahms Diagnostica Dynotest Anti-TG (1999), cited by 1
- K020348: Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising Standards/Calibrators (2002), cited by 1
- K051890: Roche Diagnostics Cobas Elecsys Anti-Tpo (2005), cited by 1
- K003414: Varelisa TG (Thyroglobulin) Antibodies, (2000), cited by 1
- K963695: Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz (1997), cited by 1

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