# NVI: Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

- Device class: 2; regulation: 21 CFR 862.3100; FDA's rule: 510(k) required
- FDA decisions: 1
- 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)
- 2005: 1

## Most-cited predicates
- K043341: Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System (2005), cited by 2

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