BD Vaginal Panel

The BD Vaginal Panel is an automated qualitative diagnostic test that detects DNA from bacteria associated with bacterial vaginosis, Candida species causing vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swab specimens. It uses real-time PCR with fluorogenic probes to identify these three common causes of vaginitis/vaginosis in symptomatic women.

The device uses the same PCR technology, specimen type (vaginal swabs), collection kit, extraction method (magnetic affinity beads with lyticase), on-board lysis, and detection channels as the predicate device. The primary difference is software enabling result masking per specimen—allowing laboratories to report results for individual target groups (BV, VVC, or TV) or any combination, rather than always reporting all three conditions.

Not stated in this summary.

Substantial equivalence is supported because the submitted device maintains identical intended use, specimen type, PCR technology, reagent composition, extraction methodology, and detection logic compared to the predicate. The added capability to selectively mask and report subsets of conditions does not alter specimen handling, test execution, or the underlying analytical performance of each target assay. Since BV, VVC, and TV are biologically distinct conditions with no bearing on each other, allowing selective reporting of only ordered conditions introduces no clinical or analytical impact—the assay simply does not display results for unordered targets rather than changing how they are detected or interpreted.