510(k) Report

De Novo · Granted

Granted

Aptima Trichomonas Vaginalis Assay

DEN110012De NovoGranted Apr 19, 20116-day reviewClass II21 CFR 866.3860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gen-Probe Incorporated · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System

Granted on Apr 19, 2011 as a new device type through De Novo after a 6-day review. 20 later devices descend from it.

Decided
Apr 19, 2011
Review
6 days
Class
Class II
Product code
OUY
Recalls
None

20 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2020: 2 descendants cleared2022: 3 descendants cleared2013: 2 descendants cleared2015: 2 descendants cleared2023: 3 descendants cleared2016: 3 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2025: 2 descendants cleared2010201520202025
  1. This deviceDEN110012 Aptima Trichomonas Vaginalis AssayGen-Probe Incorporated · 2011
  2. Descendant · cites it directly · 11 of its ownK122062 Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc. · 2013
  3. Descendant · cites it directly · 7 of its ownK130268 BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna AssayBecton, Dickinson & CO · 2013
  4. Descendant · 2 generations on · 6 of its ownK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
  5. Descendant · 2 generations on · 4 of its ownK151565 Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems…Cepheid · 2015
  6. Descendant · 3 generations on · 3 of its ownK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2013: 22015: 22016: 32019: 12020: 22021: 22022: 32023: 32025: 2
2013high 3 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 20 · See all
  • K122062Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc. · 2013 · cites it directly11descendants
  • K130268BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna AssayBecton, Dickinson & CO · 2013 · cites it directly7descendants
  • K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · 2 generations on6descendants
  • K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid · 2015 · 2 generations on4descendants
  • K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN110012Aptima Trichomonas Vaginalis AssayGen-Probe Incorporated2011—
+1K122062Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc.2013—
+1K130268BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna AssayBecton, Dickinson & CO2013—
+2K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company20162
+2K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx…Cepheid2015—
+3K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201520
201630
201910
202020
202120
202230
202330
202520
FIG. 1 — Lineage of DEN110012, 2011–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), 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. #1 K231316 Aptima Trichomonas vaginalis Assayscore 6.6 · 2 generations · no Class I recall
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (20)

See all 20

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122062Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc.201311
K130268BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna AssayBecton, Dickinson & CO20137
K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc.20202
K220321Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…Hologic, Inc.20220

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?

  • Of its descendants, K122062 (Gen-Probe, Inc., 2013) has gone furthest, with 11 descendants of its own.

How does its category compare?

All OUY devices

OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OUY

1in 2023

2011: 12013: 22015: 22016: 32019: 12023: 1
2007high 3 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUY

110in 2016

2016: 110 days median
2007high 110 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OUY

3in 2025

2025: 3
2007high 3 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OUY

1in 2024

2021: 72022: 162023: 32024: 1
2007high 16 (2022) · low 0 (2007)2025

MAUDE reports naming product code OUY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20132—00
20140—00
20152—00
2016311000
20170—00
20180—00
20191—00
20200—00
20210—07
20220—016
20231—03
20240—01
20250—30
20260—0—

More from Gen-Probe Incorporated

87 FDA decisions under this applicant name. See the company

  • P120007/S034Aptima HPV 16 18/45 Genotype AssayGen-Probe Incorporated · 2026
  • P100042/S038Aptima HPV AssayGen-Probe Incorporated · 2026
  • P120007/S033Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45…Gen-Probe Incorporated · 2025
  • P100042/S039Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators…Gen-Probe Incorporated · 2025
  • P120007/S032Aptima HPV-GT AssayGen-Probe Incorporated · 2024

Recent decisions in OUY

The OUY category page

  • K231316Aptima Trichomonas vaginalis AssayHologic, Inc. · 2023
  • K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
  • K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 20162 recalls
  • K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert…Cepheid · 2016
  • K161182Solana Trichomonas AssayQuidel Corporation · 2016

https://510kreport.com/device/DEN110012 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN110012: Aptima Trichomonas Vaginalis Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN110012

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026