# NXO: Calprotectin, Fecal

- Device class: 2; regulation: 21 CFR 866.5180; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 228 days (middle half 219–311)
- Recalls: 3 (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)
- 2006: 1
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 5
- 2022: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K160447: Calprest NG (2016), cited by 4
- DEN060001: Phical Test (2006), cited by 2
- K130945: Calprest (2014), cited by 2
- K170993: QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer (2017), cited by 1
- K182698: LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device (2018), cited by 1
- K191718: Buhlmann fCAL turbo and CALEX Cap (2019), cited by 1
- K181012: BUHLMANN fCAL ELISA (2018), cited by 1
- K190784: BUHLMANN fCAL turbo (2019), cited by 1

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