# K231329: Aptima Neisseria gonorrhoeae Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jan 26, 2024 after 263 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
Longest line of descent: 1 generation back to K063664 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063664: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091, Gen-Probe, Inc. (2007) Summary page 5.

## Indications for use
The Aptima Neisseria gonorrhoeae (GC) Assay is an in vitro qualitative nucleic acid amplification (NAAT) test for the detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the Panther System. The assay may be used to test male urine specimens from symptomatic and asymptomatic individuals.

Source page: https://510kreport.com/device/K231329
Methodology: https://510kreport.com/methodology