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510(k) Data Aggregation

    K Number
    K982298
    Device Name
    OPTICOAT T4 EIA KIT
    Manufacturer
    BIOTECX LABORATORIES, INC.
    Date Cleared
    1999-02-03

    (217 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPTICOAT T4 EIA KIT

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

    A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "OptiCoat T, EIA Kit" (also referred to as "T4 EIA Kit"). This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Instead, it's a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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