510(k) · Cleared
ClearedXpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
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 Aug 29, 2016 as substantially equivalent to K151565 (Cepheid, 2015) after a 77-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Aug 29, 2016
- Review
- 77 days
- Class
- Class II
- Product code
- OUY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P950039 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
- 3 generations backK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
- 2 generations backK121710 Xpert CT/NGCepheid · 2012 · Recalled
- 1 generation backK151565 Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems…Cepheid · 2015
- This deviceK161619 Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems…Cepheid · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P950039 | Thinprep (R) Processor, Model TP 2000 | Hologic, Inc. | 1996 | — |
| −3 | K043224 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2005 | — |
| −2 | K121710 | Xpert CT/NG | Cepheid | 2012 | 3 |
| −1 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx… | Cepheid | 2015 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Summary page 4…ssification Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device Cepheid Xpert TV Assay Assay: [510(k) #K151565] Predicate Device Xpert Urine Specimen Collection Kit Assay: [510(k) #K151565]… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K151565.
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. 2016, 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 and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The…
Read the full statement (199 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 and male urine specimens, endocervical swab specimens, and 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 female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161619: Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161619
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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