# MTG: Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 7
- Recalls: 2 (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: 9
- 2018: 7
- 2019: 9
- 2020: 13
- 2021: 7
- 2022: 4
- 2023: 9
- 2024: 3
- 2025: 6
- 2026: 6

## Most-cited predicates
- P950021: Advia Centaur & Advia Centaur CP Psa Immunoassay (1995), cited by 1

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