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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiplex Nucleic Acid Detection System For Biothreat Agents
510(k) Number K262971
Device Name Xpert® Hemorrhagic Fever Panel
Applicant
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact Annette Hellie
Classification Product Code
QVR  
Subsequent Product Code
OOI  
Date Received08/26/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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