# JMG: Radioimmunoassay (Two-Site Solid Phase), Ferritin

- Device class: 2; regulation: 21 CFR 866.5340; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- 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)
- 1987: 2
- 1988: 1
- 1989: 1
- 1990: 1
- 1992: 2
- 1993: 2
- 1995: 1
- 1997: 3
- 2005: 1
- 2024: 1

## Most-cited predicates
- K926221: Access Ferritin Assay (1993), cited by 5
- K963498: Ferr Flex Reagent Cartridge (1997), cited by 2
- K971833: Elecsys Ferritin (1997), cited by 1
- K964282: Tina-Quant Ferritin Assay (1997), cited by 1
- K052082: Ferritin on the Access Immunoassay Systems, Model 33020 (2005), cited by 1

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