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510(k) Data Aggregation

    K Number
    K111452
    Device Name
    PRESAGE ST2 ASSAY
    Manufacturer
    CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG
    Date Cleared
    2011-12-09

    (198 days)

    Product Code
    OYG,JJX
    Regulation Number
    862.1117
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k093758
    Why did this record match?
    Product Code :

    OYG

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

    The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

    The Presage® ST2 Assay Kit Controls, Level 1 and Level 2, are designed to be used for monitoring the performance of test procedures on the Critical Diagnostics Presage® ST2 Assay kit.

    Device Description

    The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format.

    AI/ML Overview

    The provided text is a 510(k) summary for the Presage® ST2 Assay. It focuses on the device's intended use, classification, and substantial equivalence to a predicate device. It does not contain information about acceptance criteria or the specific studies conducted to demonstrate that the device meets those criteria.

    The document states: "The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure."

    Therefore, I cannot provide the requested table or detailed information about the study proving the device meets acceptance criteria, as that information is not present in the provided text.

    To answer your request, I would need a different document that describes the performance studies (e.g., clinical trials, analytical validation) and the acceptance criteria established for the Presage® ST2 Assay.

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