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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
510(k) Number K261867
Device Name Xpert Carba-R
Applicant
Cepheid®
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid®
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact Bansari Doshi
Regulation Number866.1640
Classification Product Code
POC  
Subsequent Product Codes
OOI   PMY  
Date Received06/04/2026
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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