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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K254262
Device Name Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
Applicant
Ortho Clinical Diagnostics Inc. (QuidelOrtho)
9975 Summers Ridge Rd.
San Diego,  CA  92121
Applicant Contact Marisa Pugliese
Correspondent
Ortho Clinical Diagnostics Inc. (QuidelOrtho)
9975 Summers Ridge Rd.
San Diego,  CA  92121
Correspondent Contact Marisa Pugliese
Regulation Number866.3328
Classification Product Code
PSZ  
Subsequent Product Codes
GQG   GTY   KHO  
Date Received12/30/2025
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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