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510(k) Data Aggregation

    K Number
    K070183
    Device Name
    KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2007-07-13

    (175 days)

    Product Code
    OCN
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    OCN

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

    The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to KRONUS Market Development Associates, Inc. for their Insulin Autoantibody RIA Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

    The letter only states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance for market. It refers to "indications for use" but does not provide performance metrics or study details.

    Therefore, I cannot extract the requested information from the provided text.

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