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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
510(k) Number K260021
Device Name cobas® BV/CV
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact Nicole Gasser
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact Nicole Gasser
Classification Product Code
PQA  
Date Received01/05/2026
Decision Date 07/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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