# K130268: BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Aug 23, 2013 after 200 days
- Product code: OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System)
- Device class: 2
- Regulation: 21 CFR 866.3860
- 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 DEN110012 (2011). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN110012: Aptima Trichomonas Vaginalis Assay, Gen-Probe Incorporated (2011). Our reading of the summary gave K102911, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110012, Aptima Trichomonas Vaginalis Assay (Gen-Probe Incorporated), granted Apr 19, 2011; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## 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 ProbeTecTM Trichotnonas vagina/is (TV) 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 Trichonionas vagina/is DNA in clinician-collected female endocervical swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and female urine specimens. The assay is indicated for use with asymptomnatic and symptomatic females to aid in the diagnosis of trichomoniasis.

Source page: https://510kreport.com/device/K130268
Methodology: https://510kreport.com/methodology