# DEN160001: BD MAX Vaginal Panel, BD MAX Instrument

- Pathway: De Novo (Direct)
- Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Decided: Oct 28, 2016 after 291 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
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191957: BD MAX Vaginal Panel (2019), 7 descendants of its own
- K212213: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (2022), 2 descendants of its own
- K201017: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (2021), 2 descendants of its own
- K223653: BD Vaginal Panel (2023), 1 descendant of its own
- K221160: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (2022), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN160001
Methodology: https://510kreport.com/methodology