# JLS: Radioimmunoassay, Progesterone

- Device class: 1; regulation: 21 CFR 862.1620; FDA's rule: 510(k) exempt
- FDA decisions: 57
- Recalls: 9 (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)
- 1988: 2
- 1989: 4
- 1991: 3
- 1992: 2
- 1993: 5
- 1994: 2
- 1995: 3
- 1996: 2
- 1997: 5
- 2004: 1

## Most-cited predicates
- K933269: Aia-Pack (R) Prog Assay (1993), cited by 2
- K040923: Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva (2004), cited by 1
- K955025: Axsym Progesterone (1996), cited by 1
- K972133: Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone Calibrators (Gem.C070) (1997), cited by 1
- K964841: Elecsys Progesterone Assay (1997), cited by 1

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