# LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

- Device class: 2; regulation: 21 CFR 862.1155; FDA's rule: 510(k) required
- FDA decisions: 226
- 510(k) review time 2021–2025: median 151 days (middle half 102–255)
- Recalls: 19 (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)
- 2016: 1
- 2017: 1
- 2018: 4
- 2019: 7
- 2020: 2
- 2021: 2
- 2022: 6
- 2023: 2
- 2024: 10
- 2025: 5

## Most-cited predicates
- K043443: One Step HCG Urine Pregnancy Test (2005), cited by 9
- K123436: First Response Early Result Pregnancy Test (2013), cited by 6
- K150022: Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream (2015), cited by 6
- K983090: Acon Midstream Pregnancy Test (1998), cited by 4
- K071930: One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy Test (Cassette) , Model B01C (2007), cited by 3
- K992232: First Response 1-Step Pregnancy (1999), cited by 3
- K012215: Quik-Check Home Pregnancy Test (2001), cited by 3
- K083716: First Response Early Result Pregnancy Test (Otc) (2009), cited by 2
- K030258: First Response Pregnancy Test (2003), cited by 2
- K123567: First Response Gold Digital Pregnancy Test (2013), cited by 2

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