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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
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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