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510(k) Data Aggregation

    K Number
    K982954
    Device Name
    FREE T4 MICROWELL EIA, MODEL #7019
    Manufacturer
    BIOMERICA, INC.
    Date Cleared
    1998-09-24

    (31 days)

    Product Code
    CEC
    Regulation Number
    862.1695
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FREE T4 MICROWELL EIA, MODEL #7019

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

    Free T4 EIA can be used as an in vitro Diagnostic test system for the quantitative determination of nonprotein-bound (Free) circulating Thyroxine (T4) in human serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. It is not suitable for use in determination of thyroid status in neonatal patients.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Free Thyroxine (FT4) Microwell EIA" by Biomerica, Inc. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance.

    The letter is a regulatory document indicating clearance, not a technical report detailing the device's validation studies. Therefore, I cannot provide the requested information based on the given input.

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