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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
510(k) Number K254264
Device Name Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
Applicant
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
9975 Summers Ridge Rd.
San Diego,  CA  92121
Applicant Contact Xiaoxi Wang
Correspondent
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
9975 Summers Ridge Rd.
San Diego,  CA  92121
Correspondent Contact Xiaoxi Wang
Classification Product Code
QVF  
Subsequent Product Codes
KHO   LSR  
Date Received12/30/2025
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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