# K991268: Gonostat Gonococcal Detection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sierra Diagnostics
- Decided: Aug 11, 1999 after 120 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GONOSTAT® Gonococcal Detection Kit: named in the summary without a submission number

## Indications for use
The GONOSTAT® Gonococcal Detection Kit is indicated for the presumptive detection of Neisseria gonorrhoeae based on the detection of gonococcal DNA in female endocervical and male urethral specimens. Because of some cross-reactivity with DNA from N. meningitidis and some other members of the genus Neisseria, the test cannot be used with rectal or throat specimens.

Source page: https://510kreport.com/device/K991268
Methodology: https://510kreport.com/methodology