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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K261466
Device Name Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
Applicant
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact Daniel Zweitzig
Correspondent
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact Daniel Zweitzig
Regulation Number866.5660
Classification Product Code
MOB  
Subsequent Product Code
MVJ  
Date Received05/04/2026
Decision Date 08/21/2026
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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