Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

cobas® BV/CV

K-Number: K260021 · 2026-07-16

ApplicantRoche Molecular Systems, Inc.
Decision Date2026-07-16
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas® BV/CV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2026-07-16 under 510(k) number K260021. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas® BV/CV?

cobas® BV/CV is a medical device that received FDA 510(k) clearance on 2026-07-16. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K260021.

When did cobas® BV/CV receive FDA 510(k) clearance?

cobas® BV/CV received FDA 510(k) clearance on 2026-07-16, under 510(k) number K260021.

Who is the listed applicant for cobas® BV/CV?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas® BV/CV?

The FDA product code for cobas® BV/CV is PQA.

Other records listing Roche Molecular Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsPMA P190028KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK253759cobas liat CT/NG/MG nucleic acid testK253756cobas liat CT/NG nucleic acid testPMA P140023Somatic gene mutation detection systemPMA P110020Somatic gene mutation detection system

View all 47 devices →

Related Devices (Code: PQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243725BD Vaginal PanelBecton, Dickinson and CompanyK243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheidK223653BD Vaginal PanelBecton, Dickinson and CompanyK221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheidK212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑