# CKG: Radioimmunoassay, Acth

- Device class: 2; regulation: 21 CFR 862.1025; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 238 days (middle half 238–238)
- Recalls: 5 (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: 1
- 1996: 3
- 1998: 1
- 2001: 1
- 2002: 1
- 2005: 1
- 2006: 1
- 2011: 1
- 2023: 1

## Most-cited predicates
- K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth (2006), cited by 3
- K111335: ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 (2011), cited by 1
- K960066: Immulite Acth (1996), cited by 1

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