# K032554: Gen-Probe Aptima Combo 2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Dec 31, 2003 after 134 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 K003395 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003395: Gen-Probe Aptima Combo 2 Assay, Gen-Probe, Inc. (2001) Summary page 3.

## Most influential descendants
- K080739: Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit (2008), 0 descendants of its own

## Indications for use
The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal ribonucleic acid (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal, and male urethral swab specimens, patient-collected vaginal swab specimens* and male and female urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease. *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. The APTIMA Vaginal Swab Specimen Collection Kit is for use with the APTIMA Assays for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. The APTIMA Vaginal Swab Specimen Collection Kit is intended to be used for clinician and patient collection of vaginal swab specimens according to the instructions provided. Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The APTIMA Vaginal Swab Specimen Collection Kit is not for home use.

Source page: https://510kreport.com/device/K032554
Methodology: https://510kreport.com/methodology