510(k) · Cleared
ClearedXpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Cleared on Oct 16, 2015 as substantially equivalent to K122062 (Gen-Probe, Inc., 2013) and 1 other predicate after a 128-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Oct 16, 2015
- Review
- 128 days
- Class
- Class II
- Product code
- OUY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P950039 (1996). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
- 2 generations backK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
- 1 generation backK121710 Xpert CT/NGCepheid · 2012 · Recalled
- This deviceK151565 Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems…Cepheid · 2015
- Descendant · cites it directly · 2 of its ownK200748 Visby Medical Sexual HealthVisby Medical · 2021
- Descendant · 2 generations on · 1 of its ownK220407 Visby Medical Sexual Health TestVisby Medical · 2023
- Descendant · 3 generations on · 0 of its ownK251501 Visby Medical Men's Sexual Health TestVisby Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK161619 Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems…Cepheid · 2016
Most influential descendants
Showing 4 of 4 · See all- K200748Visby Medical Sexual HealthVisby Medical · 2021 · cites it directly2descendants
- K220407Visby Medical Sexual Health TestVisby Medical · 2023 · 2 generations on1descendant
- K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc. · 2025 · 3 generations on0descendants
- K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950039 | Thinprep (R) Processor, Model TP 2000 | Hologic, Inc. | 1996 | — |
| −2 | K043224 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2005 | — |
| −1 | K121710 | Xpert CT/NG | Cepheid | 2012 | 3 |
| 0 (this device) | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx… | Cepheid | 2015 | — |
| +1 | K200748 | Visby Medical Sexual Health | Visby Medical | 2021 | — |
| +2 | K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023 | — |
| +3 | K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025 | — |
| +1 | K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I… | Cepheid | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K122062 | Aptima Trichomonas Vaginalis Assay - PantherSummary page 4…robiology (83) Advisory Panel Prescription Use Yes Predicate Device Gen-Probe® Aptima Trichomonas vaginalis Assay Assay: [510(k) #K122062] Predicate Device Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit Assay: [510(k) #K121710]… | 2013 |
| * | K121710 | Xpert CT/NGSummary page 4…Assay Assay: [510(k) #K122062] Predicate Device Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit Assay: [510(k) #K121710] Xpert CT/NG Urine Specimen Collection Kit [510(k) #K121710]… | 2012 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K200748 (Visby Medical, 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K122062.
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. 2015, 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 Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV…
Read the full statement (219 words)
The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals.
Ancillary Collection Kits:
Xpert Vaginal/Endocervical Specimen Collection Kit
The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.
Xpert Urine Specimen Collection Kit
The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. The Xpert Urine Specimen Collection Kit is intended for use with male (Xpert CT/NG Assay) and female (Xpert CT/NG Assay and Xpert TV Assay) urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151565: Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151565
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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