# NAK: System, Test, Biotinidase

- Device class: 2; regulation: 21 CFR 862.1118; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 2000: 1
- 2001: 1
- 2008: 1
- 2010: 1
- 2013: 1

## Most-cited predicates
- K010844: Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K (2001), cited by 2
- K090123: Neonatal Biotinidase Kit, Model 3018 (2010), cited by 1

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