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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
510(k) Number K222638
Device Name Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
Applicant
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Shilpa Kuttetira
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received09/01/2022
Decision Date 09/27/2023
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
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