# NUA: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

- Device class: 2; regulation: 21 CFR 866.5900; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 2005: 1
- 2006: 3
- 2007: 1
- 2008: 1
- 2009: 4
- 2016: 2

## Most-cited predicates
- DEN050004: Tag-IT Cystic Fibrosis Kit (2005), cited by 6
- K051435: Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800 (2006), cited by 2
- K060627: Tag-IT Cystic Fibrosis Kit (2006), cited by 2
- K083845: Xtag CF60 Kit V2 (2009), cited by 2
- K090901: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8 (2009), cited by 1
- K060543: Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800 (2006), cited by 1
- K063787: Inplex CF Molecular Test (2008), cited by 1

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