# LPI: Kit, Assay, Progesterone Receptor

- Device class: 3; regulation: 21 CFR 864.1860; FDA's rule: PMA required
- FDA decisions: 4
- Recalls: 0 (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)
- 1983: 1
- 1984: 4
- 1985: 3
- 1990: 2
- 1991: 1
- 1992: 2
- 1995: 2
- 1999: 1

## Most-cited predicates
- P900013: Abbott PGR-Eia Monoclonal (1990), cited by 1
- P920006: Immunocytochemical Assay to Detect Progesterone (1995), cited by 1

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