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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Deformability Cytometry For Sepsis Risk Assessment
510(k) Number K250912
Device Name IntelliSep Test
Applicant
Cytovale, Inc.
2 Tower Pl.
18th Floor
South San Francisco,  CA  94080
Applicant Contact Sarah Esterquest
Correspondent
Cytovale, Inc.
2 Tower Pl.
18th Floor
South San Francisco,  CA  94080
Correspondent Contact Sarah Esterquest
Regulation Number866.3215
Classification Product Code
QUT  
Date Received03/27/2025
Decision Date 11/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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