# LLM: Test, Antigen, Nuclear, Epstein-Barr Virus

- Device class: 1; regulation: 21 CFR 866.3235; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 272 days (middle half 272–272)
- Recalls: 1 (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)
- 1988: 4
- 1989: 6
- 1991: 2
- 1993: 2
- 1995: 4
- 1996: 2
- 1998: 2
- 1999: 1
- 2005: 1
- 2024: 1

## Most-cited predicates
- K040120: Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays (2005), cited by 4
- K946158: Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit (1995), cited by 2
- K951549: Ebna Igg Eia Test System (1996), cited by 1

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