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510(k) Data Aggregation

    K Number
    K011972
    Device Name
    DIRECT BILIRUBIN REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    2001-08-27

    (63 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for the quantitative determination of direct bilirubin in serum or plasma. Bilirubin is an organic compound formed during the catabolism of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "Direct Bilirubin Reagent." This document is an approval letter for a medical device and does not contain information about acceptance criteria, study details, or performance metrics.

    Therefore, I cannot extract the requested information from the provided input. The document confirms that the device is "substantially equivalent" to legally marketed devices, but does not present the specific data from a study to demonstrate this.

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