# K060652: Tigris DTS Gen-Probe Aptima Combo 2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Aug 17, 2006 after 157 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.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110923: Cobas 4800 CT / NG Test (2012), 10 descendants of its own
- K132270: Cobas CT/NG V2.0 Test (2013), 9 descendants of its own
- K163184: cobas® CT/NG v2.0 Test (2017), 7 descendants of its own
- K173887: cobas CT/NG for use on cobas 6800/8800 systems (2018), 6 descendants of its own
- K202408: cobas CTNG for use on cobas 6800/8800 systems (2021), 3 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 RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens1, female and male urine specimens and gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. 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 using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified. 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. Gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System have only been reviewed and cleared for use with the APTIMA Combo 2 Assay in the United States by the Food and Drug Administration (FDA).

Source page: https://510kreport.com/device/K060652
Methodology: https://510kreport.com/methodology