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510(k) Data Aggregation

    K Number
    K000363
    Date Cleared
    2000-02-18

    (14 days)

    Product Code
    Regulation Number
    866.5870
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K991179
    Date Cleared
    1999-06-17

    (71 days)

    Product Code
    Regulation Number
    866.5870
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

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

    The Zeus Scientific, Inc. Thyroglobulin IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgG autoantibodies to human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or other details of a study. The document is an FDA 510(k) clearance letter for the "Zeus Scientific, Inc., Thyroglobulin IgG ELISA Test System".

    This letter states that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, it does not include the detailed performance study results, acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case study information that you requested. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.

    Therefore, I cannot fulfill your request with the input provided.

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