# LJO: Antigen, Iha, Cytomegalovirus

- Device class: 2; regulation: 21 CFR 866.3175; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 102 days (middle half 102–102)
- Recalls: 0 (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)
- 1983: 1
- 1984: 1
- 1985: 1
- 1991: 1
- 1992: 1
- 1996: 2
- 1998: 2
- 2000: 1
- 2019: 1
- 2021: 1

## Most-cited predicates
- K001767: Diamedix IS-CMV Igm Capture Test System (2000), cited by 2
- K910003: Cytomegalovirus Antibody Screen (1991), cited by 1
- K183571: Capture-CMV (2019), cited by 1
- K841520: CMV Latex Agglutination Test Kit (1984), cited by 1

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