# LOJ: Kit, Test,Alpha-Fetoprotein For Testicular Cancer

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 224 days (middle half 217–230)
- Recalls: 5 (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)
- 1996: 1
- 1997: 4
- 1998: 4
- 1999: 1
- 2002: 5
- 2003: 1
- 2004: 3
- 2008: 2
- 2009: 2
- 2022: 2

## Most-cited predicates
- K981282: Elecsys Afp (1998), cited by 2
- K071597: Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600 (2008), cited by 2
- K983031: Vitros Immunodiagnostic Products Afp Assay (1998), cited by 1
- K981354: Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211 (1998), cited by 1
- K973351: Elecsys Afp (1997), cited by 1

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