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510(k) Data Aggregation

    K Number
    K060578
    Device Name
    CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2006-08-30

    (177 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)

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

    The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

    Device Description

    Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)

    AI/ML Overview

    I am sorry, but the provided text does not contain detailed information about acceptance criteria, study methodologies, or performance data for the Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version).

    The document is an FDA 510(k) clearance letter, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device. It states the indications for use but does not delve into the specifics of performance studies, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your detailed questions about acceptance criteria and how they were met.

    Therefore, I cannot provide the requested table or the specific details regarding the studies performed.

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