# JSX: Kit, Identification, Neisseria Gonorrhoeae

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 17
- Recalls: 1 (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)
- 1978: 1
- 1979: 2
- 1981: 3
- 1983: 4
- 1985: 3
- 1987: 1
- 1988: 2
- 1991: 1
- 1992: 1
- 1996: 1

## Most-cited predicates
- K881501: Modified Ids Rapid NH System (1988), cited by 1

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