# K091724: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 13, 2009 after 155 days
- Product code: MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia)
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003395 (2001). 3 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081825: BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay, Becton, Dickinson & CO (2008) Summary page 1.
- K062440: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091, Gen-Probe, Inc. (2006) Summary page 1.

## 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 BD ProbeTecTM Chlamydia trachomatis(CT) QX Amplified DNA Assay, when tested with the BD ViperTM System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePathTM Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePathTM Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.

Source page: https://510kreport.com/device/K091724
Methodology: https://510kreport.com/methodology