# K243725: BD Vaginal Panel

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 19, 2024 after 16 days
- Product code: PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3975
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN160001 (2016). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160001: BD MAX Vaginal Panel, BD MAX Instrument, Geneohm Sciences Canada, Inc. (Bd Diagnostics) (2016) Summary page 7.
- K191957: BD MAX Vaginal Panel, Geneohm Sciences Canada, Inc. (Bd Diagnostics) (2019) Summary page 7.
- K201017: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit, Geneohm Sciences Canada, Inc. (Bd Life Sciences) (2021) Summary page 7.
- K223653: BD Vaginal Panel, Becton, Dickinson and Company (2023) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K243725
Methodology: https://510kreport.com/methodology