cobas® BV/CV— 510(k) K260021
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K260021 for cobas® BV/CV, Substantially Equivalent on 2026-07-16. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Summary
Roche Molecular Systems' cobas BV/CV is filed under PQA, vaginitis and bacterial vaginosis nucleic acid detection systems. The record doesn't expand "BV/CV" or list targets.
Class II, 21 CFR 866.3975. Microbiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Roche filed from Pleasanton, California. The decision came 192 calendar days after receipt (January 5 to July 16, 2026).
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code PQA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3975
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code PQA
view allMore clearances from Roche Molecular Systems, Inc.
view all- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K253756 — cobas liat CT/NG nucleic acid test
- K253759 — cobas liat CT/NG/MG nucleic acid test
Data sourced from openFDA. This site is unofficial and independent of the FDA.