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510(k) Data Aggregation

    K Number
    K972976
    Device Name
    CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
    Manufacturer
    MORE DIAGNOSTICS
    Date Cleared
    1997-08-29

    (18 days)

    Product Code
    JJT
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

    Device Description

    CARDIAC MARKERS CONTROL (THREE LEVELS)

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for "Cardiac Markers Control Levels 1, 2, and 3". This letter acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

    However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies.

    The letter focuses on regulatory approval and mentions "control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations," which refers to the purpose of the control material, not a study evaluating the control material itself.

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