# K935833: LCX Neisseria Gonorrhoeae Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 6, 1996 after 881 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) culture method: named in the summary without a submission number

## Most influential descendants
- K013819: Urine Collection, Preservation and Transport System (2002), 0 descendants of its own

## Indications for use
The LCx Neisseria gonorrhoeae Assay uses LCR™ (Ligase Chain Reaction) amplification technology in the LCx Probe System for the direct, qualitative detection of a specific target nucleic acid sequence in the Opa gene of Neisseria gonorrhoeae in female endocervical and male urethral swab specimens or in male and female urine specimens from symptomatic and asymptomatic males and females.

Source page: https://510kreport.com/device/K935833
Methodology: https://510kreport.com/methodology