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510(k) Data Aggregation

    K Number
    K981522
    Device Name
    AIA-PACK TGAB ASSAY
    Manufacturer
    TOSOH MEDICS, INC.
    Date Cleared
    1998-10-08

    (163 days)

    Product Code
    JZO
    Regulation Number
    866.5870
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AIA-PACK TgAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves' disease and Hashimoto's disease.

    Device Description

    AIA-PACK TgAb Assay

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) clearance letter for the AIA-PACK TGAb Assay, which primarily states that the device is substantially equivalent to a legally marketed predicate device.

    It does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Information on sample sizes, data provenance, or details about the test set.
    3. The number or qualifications of experts or adjudication methods for ground truth.
    4. Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
    5. Information on standalone algorithm performance.
    6. The type of ground truth used.
    7. Sample size for the training set or how its ground truth was established.

    The document essentially grants market clearance based on substantial equivalence, but it does not delve into the specifics of the performance study that led to this determination.

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