# K111409: Aptima Combo 2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: May 3, 2012 after 350 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 K032194 (2003). 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)
- K032194: Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays, Gen-Probe, Inc. (2003) Summary page 2.

## Most influential descendants
- K132251: Aptima Combo 2 Assay (Panther System) (2013), 0 descendants of its own

## Indications for use
The PANTHER System is intended to fully automate amplified nucleic acid test (NAT) diagnostic assays currently developed by Gen-Probe Incorporated (San Diego, CA). 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 RNA (rRNA) from Chiamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamrydial and/or gonococcal urogenital disease using the PANTHER System as specified. On the PANTHER System, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt Solution, and patient-collected vaginal swab specimens. 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/K111409
Methodology: https://510kreport.com/methodology