# K081824: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 11, 2008 after 167 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: 1 generation back to K984631 (1999). 2 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984631: Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna Assay, Becton Dickinson Microbiology Systems (1999) Summary page 1.
- K003395: Gen-Probe Aptima Combo 2 Assay, Gen-Probe, Inc. (2001) Summary page 1.

## Most influential descendants
- K151589: BD Max CT/GC/TV, BD Max Instrument (2016), 6 descendants of its own
- K182692: BD MAX CTGCTV2, BD MAX System (2019), 3 descendants of its own
- K210585: BD CTGCTV2 (2022), 1 descendant of its own
- K202977: Alinity m STI Assay (2022), 1 descendant of its own
- K243343: BD CTGCTV2 (2025), 0 descendants of its own

## Indications for use
The BD ProbeTec Chlamydia trachomatis (CT) QX Amplified DNA Assay, when tested with the BD ViperTM System in Extracted Mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. 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/K081824
Methodology: https://510kreport.com/methodology