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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
510(k) Number K242294
Device Name DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
Applicant
Diasys Diagnostic Systems GmbH
Alte Strasse 9
Holzheim,  DE 65558
Applicant Contact Jan Gorka
Correspondent
Imagenix, Inc.
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact Stephen Gorski
Regulation Number866.3215
Classification Product Code
PTF  
Subsequent Product Code
JJX  
Date Received08/02/2024
Decision Date 05/09/2025
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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