# MTF: Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 8
- Recalls: 6 (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: 12
- 2018: 10
- 2019: 8
- 2020: 14
- 2021: 6
- 2022: 5
- 2023: 10
- 2024: 4
- 2025: 8
- 2026: 9

## Most-cited predicates
- P850048: Tandem-R Psa Immunoradiometric Assay (1986), cited by 3
- P910007: Axsym Total Psa & Architect Total Psa (1991), cited by 2
- P910065: Aia-Pack Psa (1993), cited by 1

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