# JXA: Kit, Screening, Urine

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 44
- 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)
- 1988: 3
- 1989: 2
- 1990: 1
- 1991: 1
- 1992: 1
- 1993: 1
- 1994: 1
- 1995: 4
- 1998: 2
- 2001: 1

## Most-cited predicates
- K924218: Bac-T-Screen (1993), cited by 1
- K921045: Diaslide Urine Culturing Device (1992), cited by 1
- K011043: Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti) (2001), cited by 1

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