# K260021: cobas® BV/CV

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jul 16, 2026 after 192 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: 2 generations back to DEN160001 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191957: BD MAX Vaginal Panel, Geneohm Sciences Canada, Inc. (Bd Diagnostics) (2019) Summary page 5.

## Indications for use
cobas BV/CV for use on the cobas 6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of bacteria (Gardnerella vaginalis, Lactobacillus spp., and Atopobium vaginae) associated with bacterial vaginosis (BV) and yeast (Candida spp. listed below) associated with Candida vaginitis (CV) from self-collected vaginal swab specimens and clinician-collected vaginal swab specimens, all collected in cobas PCR Media. The assay amplifies specific DNA targets to detect organisms associated with BV (i.e., G. vaginalis, L. crispatus, L. gasseri, L. jensenii, and A. vaginae) and specific organisms associated with CV (i.e., C. albicans, C. dubliniensis, C. glabrata, C. krusei, C. tropicalis, and C. parapsilosis) but does not differentiate which BV and/or CV organism(s) is present. This test is intended as an aid in the diagnosis of BV and/or CV in symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both.

Source page: https://510kreport.com/device/K260021
Methodology: https://510kreport.com/methodology