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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alzheimer’S Disease Pathology Assessment Test
510(k) Number K221842
Device Name Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Greg Mondics
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Greg Mondics
Classification Product Code
QSE  
Date Received06/24/2022
Decision Date 12/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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