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510(k) Data Aggregation

    K Number
    K981521
    Device Name
    AIA-PACK TPOAB 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 TPOAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroid peroxidase antibodies (TPOAb) 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

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "AIA-PACK TPOAb Assay". It approves the device for marketing and states its intended use. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document is primarily an approval letter and an "Indication for Use Statement," not a study report or a detailed description of validation.

    To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a validation protocol.

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