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510(k) Data Aggregation

    K Number
    K021636
    Device Name
    ALBUMIN REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    2002-07-17

    (61 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for an "Albumin Reagent" device, indicating that it has been found substantially equivalent to a legally marketed predicate device. It defines the intended use of the device but does not include any performance data or a description of a study.

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