# CEP: Radioimmunoassay, Luteinizing Hormone

- Device class: 1; regulation: 21 CFR 862.1485; FDA's rule: 510(k) exempt
- FDA decisions: 143
- Recalls: 4 (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)
- 1994: 6
- 1995: 5
- 1996: 5
- 1997: 5
- 1998: 3
- 1999: 3
- 2000: 1
- 2001: 3
- 2002: 3
- 2003: 1

## Most-cited predicates
- K981271: Clearplan Easy Ovulation Test (1998), cited by 5
- K894579: Clearplan Easy (1989), cited by 2
- K983113: Besure Plus One-Step Home Ovulation Predictor Kit (1998), cited by 1
- K964694: Elecsys LH Assay (1997), cited by 1
- K962041: Acs LH2 Immunoassay (1996), cited by 1
- K991386: Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick) (1999), cited by 1
- K910198: Ciba Corning Acs LH Immunoassay (1991), cited by 1
- K953063: Conceive Ovulation Predictor (1995), cited by 1
- K953581: First Response Ovulation Predictor Test (1995), cited by 1
- K900779: Enzymun Test (R) LH (1990), cited by 1

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