510(k) · Cleared
ClearedBD MAX CTGCTV2, BD MAX System
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 Jan 8, 2019 as substantially equivalent to K151589 (Becton, Dickinson and Company, 2016) after a 103-day review. Its family tree reaches back 3 generations to 1999. 3 later devices descend from it.
- Decided
- Jan 8, 2019
- Review
- 103 days
- Class
- Class II
- Product code
- OUY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K984631 (1999). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
- 2 generations backK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- 1 generation backK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
- This deviceK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
- Descendant · cites it directly · 1 of its ownK210585 BD CTGCTV2Becton, Dickinson and Company · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK243343 BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025
- Descendant · cites it directly · 0 of its ownK193081 Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation…Rheonix, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K210585BD CTGCTV2Becton, Dickinson and Company · 2022 · cites it directly1descendant
- K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025 · 2 generations on0descendants
- K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software)…Rheonix, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… | Becton Dickinson Microbiology Systems | 1999 | 2 |
| −2 | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| −1 | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | 2 |
| 0 (this device) | K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019 | — |
| +1 | K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022 | 1 |
| +2 | K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025 | — |
| +1 | K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and… | Rheonix, Inc. | 2021 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K151589 | BD Max CT/GC/TV, BD Max InstrumentSummary page 6…icrobiology (83) Product Code(s): MKZ Chlamydia trachomatis LSL Neisseria gonorrhoeae OUY Trichomonas vaginalis Predicate Device: BD MAX™ CT/GC/TV [510(k) K151589] Performance Standards: Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas… | 2016 |
What descends from it? (3)
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 20 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K210585 (Becton, Dickinson and Company, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K151589.
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. 2019, 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™ CTGCTV2 assay, performed on the BD MAX™ System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from: e Chlamydia trachomatis (CT) e Neisseria gonorrhoeae (GC) e Trichomonas vaginalis (TV) The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine…
Read the full statement (263 words)
The BD MAX™ CTGCTV2 assay, performed on the BD MAX™ System, incorporates automated DNA
extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:
e Chlamydia trachomatis (CT)
e Neisseria gonorrhoeae (GC)
e Trichomonas vaginalis (TV)
The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal
swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the
detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in
PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of
chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.
Ancillary Collection kits:
The BD MAX 3-in-1 Swab Collection Kit is intended to be used in clinical settings according to the
instructions provided for collection and transport of vaginal and endocervical swab specimens. This transport
system is for use for testing with BD MAX products.
The BD MAX Urine Transport Kit is intended to be used in clinical settings according to the instructions
provided for collection, preservation and transport of urine specimens. This transport system is for use for testing
with the BD MAX products.
The BD MAX LBC Sample Buffer Tubes are intended to be used in clinical settings according to the
instructions provided for the preservation and transport of Liquid-Based Cytology (LBC) specimens. This
transport system is for use for testing with the BD MAX products.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182692: BD MAX CTGCTV2, BD MAX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182692
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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