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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
510(k) Number K260047
Device Name cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact Jinali Bhavsar
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact Gaila Balniene
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received01/07/2026
Decision Date 08/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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