# LSE: Epstein-Barr Virus, Other

- Device class: 1; regulation: 21 CFR 866.3235; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 272 days (middle half 272–272)
- 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)
- 2001: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2006: 3
- 2008: 1
- 2009: 1
- 2017: 2
- 2024: 1
- 2026: 2

## Most-cited predicates
- K946157: Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa Kit (1995), cited by 2
- K060204: Liaison EA Igg (2006), cited by 1
- K946159: Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit (1995), cited by 1
- K062213: Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System (2006), cited by 1
- K973123: EA-D Igg Elisa Test System (1998), cited by 1
- K980912: Vca Igg Elisa Test System (1998), cited by 1
- K872617: Ebv-EA Test (1988), cited by 1
- K062211: Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System (2006), cited by 1
- K992191: Eti-EA-G Assay (1999), cited by 1

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