# K043224: Gen-Probe Aptima Combo 2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Aug 9, 2005 after 260 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 P950039 (1996). 2 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 24 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 2.
- P950039: Thinprep (R) Processor, Model TP 2000, Hologic, Inc. (1996) Summary page 2.

## Most influential descendants
- K092704: Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03 (2010), 11 descendants of its own
- 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
- K121710: Xpert CT/NG (2012), 7 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 (CT) and/or Neisseria gonorrhoeae (GC) in clinician-collected endocervical, vaginal, and male urethral swab specimens, patient-collected vaginal swab specimens*, and female and male urine specimens. The assay is also intended for use with testing of 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. *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 GEN-PROBE' APTIMA ® Specimen Transfer Kit is only for use with GEN-PROBE APTIMA assays for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae. The GEN-PROBE APTIMA Specimen Transfer Kit allows for APTIMA Assay testing of gynecological specimens collected and processed by the Cytyc ThinPrep 2000 Processor according to the instructions provided.

Source page: https://510kreport.com/device/K043224
Methodology: https://510kreport.com/methodology