De Novo · Granted
GrantedBD MAX Vaginal Panel, BD MAX Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geneohm Sciences Canada, Inc. (Bd Diagnostics) · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Granted on Oct 28, 2016 as a new device type through De Novo after a 291-day review. 11 later devices descend from it.
- Decided
- Oct 28, 2016
- Review
- 291 days
- Class
- Class II
- Product code
- PQA
- Recalls
- None
11 later devices descend from it, 5 citing it directly.
- This deviceDEN160001 BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2016
- Descendant · cites it directly · 7 of its ownK191957 BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2019
- Descendant · 2 generations on · 2 of its ownK212213 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022
- Descendant · cites it directly · 2 of its ownK201017 BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences) · 2021
- Descendant · 2 generations on · 1 of its ownK223653 BD Vaginal PanelBecton, Dickinson and Company · 2023
- Descendant · 3 generations on · 1 of its ownK221160 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K191957BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2019 · cites it directly7descendants
- K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022 · 2 generations on2descendants
- K201017BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences) · 2021 · cites it directly2descendants
- K223653BD Vaginal PanelBecton, Dickinson and Company · 2023 · 2 generations on1descendant
- K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016 | — |
| +1 | K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019 | — |
| +2 | K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022 | — |
| +1 | K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021 | — |
| +2 | K223653 | BD Vaginal Panel | Becton, Dickinson and Company | 2023 | — |
| +3 | K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (11)
See all 115 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?
- Of its descendants, K191957 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2019) has gone furthest, with 7 descendants of its own.
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. 2016, 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 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 quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis.…
Read the full statement (169 words)
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 quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. 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
• Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
• Candida glabrata
• Candida krusei
• Trichomonas vaginalis
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/DEN160001 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN160001: BD MAX Vaginal Panel, BD MAX Instrument.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160001
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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