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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 K253051
Device Name i-STAT hs-TnI cartridge with the i-STAT Alinity System
Applicant
Abbott Point of Care, Inc.
400 College Rd. E.
Princeton,  NJ  08540
Applicant Contact Jacquelyn Gesumaria
Correspondent
Abbott Point of Care, Inc.
400 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact Jacquelyn Gesumaria
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
JJE  
Date Received09/22/2025
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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