# LTJ: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 37
- Recalls: 10 (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)
- 2016: 2
- 2017: 10
- 2018: 7
- 2019: 2
- 2020: 1
- 2021: 2
- 2023: 2
- 2024: 3
- 2025: 3
- 2026: 3

## Most-cited predicates
- K964351: Elecsys Psa Assay (1997), cited by 2
- P000021: Dimension (R) RXL Psa Flex (R) Reagent Cartridge (2001), cited by 1
- K124056: Frend Psa Plus (Reagent Cartridge) (2013), cited by 1
- P920030: Ciba Corning Acs Psa Immunoassay (1998), cited by 1

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