510(k) · Cleared
ClearedBD Vaginal Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Cleared on Dec 19, 2024 as substantially equivalent to DEN160001 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2016) and 3 other predicates after a 16-day review. Its family tree reaches back 4 generations to 2016.
- Decided
- Dec 19, 2024
- Review
- 16 days
- Class
- Class II
- Product code
- PQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to DEN160001 (2016). No later device cites it as a predicate yet.
- Root · 4 generations backDEN160001 BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2016
- 3 generations backK191957 BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2019
- 2 generations backK201017 BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences) · 2021
- 1 generation backK223653 BD Vaginal PanelBecton, Dickinson and Company · 2023
- This deviceK243725 BD Vaginal PanelBecton, Dickinson and Company · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016 | — |
| −3 | K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019 | — |
| −2 | K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021 | — |
| −1 | K223653 | BD Vaginal Panel | Becton, Dickinson and Company | 2023 | — |
| 0 (this device) | K243725 | BD Vaginal Panel | Becton, Dickinson and Company | 2024 | — |
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 PQA? 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 PQA device
- #1 K260021 cobas® BV/CVscore 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | DEN160001 | BD MAX Vaginal Panel, BD MAX InstrumentSummary page 7…System OOI Real Time Nucleic Acid Amplification System NSU Instrumentation for Clinical Multiplex Test Systems Predicate Device BD Vaginal Panel (DEN160001, K191957, K201017, K223653) Device Establishment Registration Number: 1119779 Intended Use BD Vaginal Panel (For use with BD… | 2016 |
| * | K191957 | BD MAX Vaginal PanelSummary page 7…OOI Real Time Nucleic Acid Amplification System NSU Instrumentation for Clinical Multiplex Test Systems Predicate Device BD Vaginal Panel (DEN160001, K191957, K201017, K223653) Device Establishment Registration Number: 1119779 Intended Use BD Vaginal Panel (For use with BD COR™ Syst… | 2019 |
| * | K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitSummary page 7…Real Time Nucleic Acid Amplification System NSU Instrumentation for Clinical Multiplex Test Systems Predicate Device BD Vaginal Panel (DEN160001, K191957, K201017, K223653) Device Establishment Registration Number: 1119779 Intended Use BD Vaginal Panel (For use with BD COR™ System) The… | 2021 |
| * | K223653 | BD Vaginal PanelSummary page 7…me Nucleic Acid Amplification System NSU Instrumentation for Clinical Multiplex Test Systems Predicate Device BD Vaginal Panel (DEN160001, K191957, K201017, K223653) Device Establishment Registration Number: 1119779 Intended Use BD Vaginal Panel (For use with BD COR™ System) The BD Vagina… | 2023 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate DEN160001.
How does its category compare?
All PQA devicesPQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PQA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PQA
87in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQA
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQA
3in 2025
MAUDE reports naming product code PQA, 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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 0 |
| 2019 | 3 | 87 | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 7 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and…
Read the full statement (421 words)
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
• Bacterial vaginosis (BV) markers (Individual markers are not reported)
o Lactobacillus spp. (L. crispatus and L. jensenii)
o Gardnerella vaginalis
o Atopobium vaginae
o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
o Megasphaera-1
• Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups)
o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
o Candida glabrata
o Candida krusei
• Trichomonas vaginalis (TV)
The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.
The BD MAX™ Vaginal Panel performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
• Bacterial vaginosis markers (Individual markers not reported)
o Lactobacillus spp. (L. crispatus and L. jensenii)
o Gardnerella vaginalis
o Atopobium vaginae
o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
o Megasphaera-1
• Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups)
o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis)
o Candida glabrata
o Candida krusei
• Trichomonas vaginalis (TV)
The assay may be used to detect BV, VVC, and/or TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD MAX™ Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243725: BD Vaginal Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243725
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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