# LQP: Campylobacter Spp.

- Device class: 1; regulation: 21 CFR 866.3110; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 235 days (middle half 220–251)
- 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)
- 1986: 2
- 1988: 1
- 1998: 1
- 2009: 2
- 2018: 2
- 2019: 2
- 2021: 2

## Most-cited predicates
- K191456: Campylobacter Quik Chek (2019), cited by 2
- K982315: Prospect Campylobacter Microplate Assay (1998), cited by 2
- K083464: Premier Campy, Model 618096 (2009), cited by 1
- K090700: Immunocard Stat Campy, Model 751530 (2009), cited by 1

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