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510(k) Data Aggregation

    K Number
    K052359
    Device Name
    IBL CORTISOL LIA TEST KIT
    Manufacturer
    Lehnus & Associates Consulting
    Date Cleared
    2005-10-03

    (38 days)

    Product Code
    CGR
    Regulation Number
    862.1205
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IBL CORTISOL LIA TEST KIT

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

    The IBL Cortisol Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.

    The Cortisol LIA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.

    Device Description

    IBL Cortisol LIA test kit

    AI/ML Overview

    This is an FDA Premarket Notification (510(k)) letter for the IBL Cortisol LIA test kit. The letter itself does not contain the detailed acceptance criteria or the study results. It primarily states that the device has been found substantially equivalent to a predicate device.

    Therefore, I cannot provide the requested information from the provided text because it is not present in this document. The document confirms that the device is cleared for marketing but does not detail the technical performance studies and acceptance criteria that led to that clearance.

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