510(k) · Cleared
ClearedBD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Cleared on Aug 23, 2013 as substantially equivalent to DEN110012 (Gen-Probe Incorporated, 2011) after a 200-day review. Its family tree reaches back 1 generation to 2011. 7 later devices descend from it.
- Decided
- Aug 23, 2013
- Review
- 200 days
- Class
- Class II
- Product code
- OUY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN110012 (2011). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN110012 Aptima Trichomonas Vaginalis AssayGen-Probe Incorporated · 2011
- This deviceK130268 BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna AssayBecton, Dickinson & CO · 2013
- Descendant · cites it directly · 6 of its ownK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
- Descendant · 3 generations on · 1 of its ownK210585 BD CTGCTV2Becton, Dickinson and Company · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK202977 Alinity m STI AssayAbbott Molecular, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK243343 BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · cites it directly6descendants
- K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019 · 2 generations on3descendants
- K210585BD CTGCTV2Becton, Dickinson and Company · 2022 · 3 generations on1descendant
- K202977Alinity m STI AssayAbbott Molecular, Inc. · 2022 · 2 generations on1descendant
- K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN110012 | Aptima Trichomonas Vaginalis Assay | Gen-Probe Incorporated | 2011 | — |
| 0 (this device) | K130268 | BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna Assay | Becton, Dickinson & CO | 2013 | — |
| +1 | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | 2 |
| +2 | K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019 | — |
| +3 | K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022 | 1 |
| +2 | K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022 | — |
| +4 | K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OUY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OUY device
- #1 K231316 Aptima Trichomonas vaginalis Assayscore 6.6 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN110012 | Aptima Trichomonas Vaginalis Assay 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. | 2011 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151589 | BD Max CT/GC/TV, BD Max Instrument | 2016 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OUY devicesOUY Trichomonas Vaginalis Nucleic Acid Amplification Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OUY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OUY
110in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUY
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUY
1in 2024
MAUDE reports naming product code OUY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 110 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 3 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130268: BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130268
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026