510(k) · Cleared
Recalled · Class II · 2019BD Max CT/GC/TV, BD Max Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Cleared on Sep 6, 2016 as substantially equivalent to K081824 (Becton, Dickinson & CO, 2008) and 2 other predicates after a 452-day review. Its family tree reaches back 2 generations to 1999. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 6, 2016
- Review
- 452 days
- Class
- Class II
- Product code
- OUY
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K984631 (1999). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
- 1 generation backK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- This deviceK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016
- Descendant · cites it directly · 3 of its ownK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
- Descendant · 2 generations on · 1 of its ownK210585 BD CTGCTV2Becton, Dickinson and Company · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK202977 Alinity m STI AssayAbbott Molecular, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK243343 BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025
- Descendant · 2 generations on · 0 of its ownK222379 Alinity m STI AssayAbbott Molecular, Inc. · 2023 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019 · cites it directly3descendants
- K210585BD CTGCTV2Becton, Dickinson and Company · 2022 · 2 generations on1descendant
- K202977Alinity m STI AssayAbbott Molecular, Inc. · 2022 · cites it directly1descendant
- K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025 · 3 generations on0descendants
- K222379Alinity m STI AssayAbbott Molecular, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… | Becton Dickinson Microbiology Systems | 1999 | 2 |
| −1 | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| 0 (this device) | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | — |
| +1 | K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019 | — |
| +2 | K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022 | 1 |
| +1 | K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022 | — |
| +3 | K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025 | — |
| +2 | K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssaySummary page 5…Neisseria gonorrhoeae OUY Trichomonas vaginalis Predicate Device Becton Dickinson ProbeTec™ ET Chlamydia trachomatis (CT) QX Amplified DNA Assay [510(k) K081824] Becton Dickinson ProbeTec™ ET Neisseria gonorrhoeae (GC) QX Amplified DNA Assay [510(k) K081825] Becton Dickinson ProbeTec™ Tr… | 2008 |
| * | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssaySummary page 5…ProbeTec™ ET Chlamydia trachomatis (CT) QX Amplified DNA Assay [510(k) K081824] Becton Dickinson ProbeTec™ ET Neisseria gonorrhoeae (GC) QX Amplified DNA Assay [510(k) K081825] Becton Dickinson ProbeTec™ Trichomonas Vaginalis (TV) QX Amplified DNA Assay [510(k) K130268] Device Establishment GeneOhm Sc… | 2008 |
| * | K130268 | BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna AssaySummary page 5…son ProbeTec™ ET Neisseria gonorrhoeae (GC) QX Amplified DNA Assay [510(k) K081825] Becton Dickinson ProbeTec™ Trichomonas Vaginalis (TV) QX Amplified DNA Assay [510(k) K130268] Device Establishment GeneOhm Sciences Canada, Inc. (BD Diagnostics) 2555 Boul. du Parc-Technologique Quebec, QC G1P 4S5 Canada… | 2013 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2019 | Class II | Z-2331-2019 | Process control | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| Jul 18, 2017 | Class II | Z-0394-2018 | Use error | BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K182692 (Becton, Dickinson and Company, 2019) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K081824.
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 BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected…
Read the full statement (108 words)
The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151589: BD Max CT/GC/TV, BD Max Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151589
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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