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510(k) Data Aggregation

    K Number
    K020349
    Device Name
    ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
    Manufacturer
    AXIS-SHIELD DIAGNOSTICS, LTD.
    Date Cleared
    2002-05-02

    (87 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

    The test is for the quantitative measurement of the IgG class of auto-antibodies to anti-Thyroglobulin (anti-Tg) in human serum or plasma (EDTA or heparin) to aid in the diagnosis of thyroid disease

    Device Description

    Abbott AxSYM® anti-Thyroglobulin (anti-Tg) Microparticle Enzyme Immunoassay (MEIA)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Axis-Shield Diagnostics Ltd. regarding the Abbott AxSYM® anti-Thyroglobulin (anti-Tg) Microparticle Enzyme Immunoassay (MEIA). It largely focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of detailed performance data and study design information is typically found in the 510(k) summary or full submission, which is not provided in these pages.

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