# CGR: Radioimmunoassay, Cortisol

- Device class: 2; regulation: 21 CFR 862.1205; FDA's rule: 510(k) required
- FDA decisions: 84
- 510(k) review time 2021–2025: median 132 days (middle half 113–223)
- Recalls: 6 (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)
- 1997: 1
- 1998: 1
- 1999: 1
- 2002: 1
- 2004: 1
- 2005: 2
- 2006: 2
- 2021: 3
- 2023: 1
- 2025: 1

## Most-cited predicates
- K050202: Cortisol and Cortisol Calibrators on the Access Immunoassay Systems (2005), cited by 2
- K931409: Immulite Cortisol (1993), cited by 2
- K954733: Access Cortisol Assay (Modification) (1995), cited by 1
- K810891: Coat-a-Count Cortisol Ria Kit (1981), cited by 1
- K850141: Active Cortisol DSL 2000-SP (1985), cited by 1
- K962208: Nichols Advantage Chemiluminescence Cortisol Kit (1997), cited by 1
- K983990: Vitros Immunodiagnostic Products Cortisol Assay (1998), cited by 1

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