# K063664: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Jan 25, 2007 after 48 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) GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae: named in the summary without a submission number

## Most influential descendants
- K231329: Aptima Neisseria gonorrhoeae Assay (2024), 0 descendants of its own

## Indications for use
The GEN-PROBE APTIMA® Assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the TIGRIS® DTS® Automated Analyzer or semi-automated instrumentation as specified. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal swab specimens; patient-collected vaginal swab specimens; and female and male urine. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients collected in the PreservCyt® Solution and processed with the Cytyc ThinPrep® 2000 System. Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

Source page: https://510kreport.com/device/K063664
Methodology: https://510kreport.com/methodology