# LOK: Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 11
- 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)
- 2017: 6
- 2018: 8
- 2019: 6
- 2020: 15
- 2021: 8
- 2022: 6
- 2023: 9
- 2024: 4
- 2025: 5
- 2026: 7

## Most-cited predicates
- P820060: Abbott Afp-Eia Diagnostic Kit for Cancer (1983), cited by 4
- P980041: Access Afp Immunoassay System (1999), cited by 1
- P930036: Advia Centaur Afp Reagents and Calibrators (1995), cited by 1

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