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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K252393
Device Name VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact Kristine Tkacs
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact Kristine Tkacs
Regulation Number862.1215
Classification Product Code
MMI  
Date Received07/31/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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