# K043144: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Mar 14, 2005 after 119 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.
10 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K121710: Xpert CT/NG (2012), 7 descendants of its own
- K151565: Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit (2015), 4 descendants of its own
- K200748: Visby Medical Sexual Health (2021), 2 descendants of its own
- K220407: Visby Medical Sexual Health Test (2023), 1 descendant of its own
- K173840: Xpert CT/NG (2018), 1 descendant of its own

Source page: https://510kreport.com/device/K043144
Methodology: https://510kreport.com/methodology