# NIG: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 75 days (middle half 75–75)
- Recalls: 8 (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)
- 2002: 3
- 2003: 2
- 2005: 2
- 2011: 1
- 2019: 1
- 2020: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K020566: Fujirebio Diagnostics CA 19-9 Ria (2002), cited by 5
- K031393: Bayer Advia Centaur CA 19-9 Assay (2003), cited by 2
- K052889: Vitros CA 19-9 (2005), cited by 1
- K052000: Architect CA 19-9XR Assay (2005), cited by 1
- K191973: Lumpipulse G CA19-9-N (2019), cited by 1

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