BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    i-STAT hs-TnI cartridge with the i-STAT Alinity System

    K Number: K253051 · Decision Jun 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    94
    Applicant Total
    20
    Review Days
    262

    Basic Information

    Device Name
    i-STAT hs-TnI cartridge with the i-STAT Alinity System
    K Number
    K253051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Point of Care, Inc.
    Date Received
    September 22, 2025
    Decision Date
    June 11, 2026
    Product Code
    MMI
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MMI Immunoassay Method, Troponin Subunit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MMI), ordered by most recent decision date.

    VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access hsTnI

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access hsTnI

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT hs-TnI cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica® IM High-Sensitivity Troponin I (TnIH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PATHFAST®hs-cTnI-II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Abbott Point of Care, Inc.

    K Number Device Name
    K244014 i-STAT CG4+ cartridge with the i-STAT 1 System
    K240984 i-STAT hs-TnI cartridge with the i-STAT 1 System
    K230275 i-STAT CG8+ cartridge with the i-STAT 1 System
    K230285 i-STAT CG8+ cartridge with the i-STAT 1 System
    K230300 i-STAT CG8+ cartridge with the i-STAT 1 System
    K223857 i-STAT G3+ cartridge with the i-STAT 1 System
    K223755 i-STAT G cartridge with the i-STAT 1 System
    K223710 i-STAT CG8+ cartridge with the i-STAT 1 System
    K210958 i-STAT CHEM8+ cartridge with the i-STAT 1 System
    K200492 i-STAT CG4+ Cartridge with the i-STAT 1 System
    Search all 20 clearances from Abbott Point of Care, Inc. →