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510(k) Data Aggregation

    K Number
    K991720
    Device Name
    KRONUS OPTIQUANT THYROGLOBULIN KIT
    Manufacturer
    UNCHANGED
    Date Cleared
    1999-08-09

    (81 days)

    Product Code
    MSW
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    is intended for the quantitative determination of thyroglobulin (Tg) in human serum as an aid in the detection of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioiodine), and who lack serum thyroglobulin antibodies.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA document does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is primarily a notification letter from the FDA regarding the substantial equivalence of the "Kronus Optiquant Thyroglobulin Kit" to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory classifications, general controls, and points of contact for additional information.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text.

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