# NGE: Test, Luteinizing Hormone (Lh), Over The Counter

- Device class: 1; regulation: 21 CFR 862.1485; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 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)
- 1985: 1
- 1986: 1
- 1998: 2
- 1999: 1
- 2002: 1

## Most-cited predicates
- K981207: Clearplan Easy Fertility Monitor (1998), cited by 2
- K850579: Cue Fertility Monitor (1985), cited by 1

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