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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm, If, Epstein-Barr Virus
510(k) Number K260233
Device Name Elecsys EBV IgM
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Cynthia Aker
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Cynthia Aker
Regulation Number866.3235
Classification Product Code
LJN  
Subsequent Product Codes
LLM   LSE  
Date Received01/26/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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