510(k) · Cleared
Clearedcobas® BV/CV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Cleared on Jul 16, 2026 as substantially equivalent to K191957 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2019) after a 192-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Jul 16, 2026
- Review
- 192 days
- Class
- Class II
- Product code
- PQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160001 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) 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 K243725 BD Vaginal Panelscore 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191957 | BD MAX Vaginal PanelSummary page 5…ation Name vaginitis and bacterial vaginosis Product Code PQA Predicate Device BD MAX™ Vaginal Panel (DEN160001, K191957(current)) Establishment Registration Roche Molecular Systems, Inc. (2243471)… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K191957.
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. 2026, 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?
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…
Read the full statement (153 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260021: cobas® BV/CV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260021
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026