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510(k) Data Aggregation

    K Number
    K972190
    Device Name
    THYROGLOBULIN ASSAY SYSTEM
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    1997-07-14

    (56 days)

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

    THYROGLOBULIN ASSAY SYSTEM

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

    The Thyroglobulin ELISA Assay is intended for the quantitative determination of thyroglobulin (TG) in human serum or plasma in patients who do not have TG antibodies; to aid in confirming the diagnosis of thyroid diseases, such as Graves' Disease; and to monitor for the absence of thyroglobulin in thyroidectomized patients.

    Device Description

    Not Found

    AI/ML Overview

    Thislooks like a 510(k) clearance letter for an ELISA assay, not a study evaluating an AI/ML device. Therefore, the questions regarding acceptance criteria, study design, and performance metrics for an AI/ML device are not applicable to the provided document.

    The document discusses the regulatory clearance of the "ALPCO Thyroglobulin ELISA Assay" based on its substantial equivalence to a predicate device, as per the FDA's 510(k) process. It outlines the intended use of the assay for quantitative determination of thyroglobulin in human serum or plasma to aid in diagnosing thyroid diseases and monitoring thyroidectomized patients.

    Here's why the questions are not applicable:

    • Acceptance Criteria for AI/ML and Reported Device Performance: This document does not describe performance metrics like sensitivity, specificity, AUC, etc., that would be relevant for an AI/ML device study. It's about a laboratory assay.
    • Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Study, Ground Truth Type, Training Set Size, Training Set Ground Truth: All these questions pertain to the design and results of a clinical study or validation for an AI/ML system, which is not what this document represents.

    In summary, the provided text is a regulatory clearance letter for an in-vitro diagnostic (ELISA) assay, not a study report or clinical trial documentation for an AI/ML-driven medical device. Therefore, none of the requested information can be extracted.

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