# LKT: Respiratory Syncytial Virus, Antigen, Antibody, Ifa

- Device class: 1; regulation: 21 CFR 866.3480; FDA's rule: 510(k) exempt
- FDA decisions: 23
- 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)
- 1984: 2
- 1985: 3
- 1986: 2
- 1987: 5
- 1988: 2
- 1989: 1
- 1991: 3
- 1994: 2
- 1999: 1
- 2008: 1

## Most-cited predicates
- K081928: D3 Duet Dfa RSV/Respiratory Virus Screening Kit (2008), cited by 4

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