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    K Number
    K180607
    Device Name
    Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
    Manufacturer
    KRONUS, Inc.
    Date Cleared
    2018-11-23

    (261 days)

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

    Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

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

    The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA approval letter and an "Indications for Use" statement for the KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit. It does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

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