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510(k) Data Aggregation

    K Number
    K981857
    Device Name
    QUANTA LITE TPO ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-07-29

    (63 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An enzyme linked immunosorbant assay (ELISA) for the semiquantitative detection of antibodies to thyroid peroxidase (TPO) in human serum to aid in the diagnosis of autoimmune thyroid diseases such as Hashimoto's Thyroiditis and Graves Disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Quanta Lite TPO ELISA." This document primarily focuses on regulatory approval and does not contain the specific technical details, acceptance criteria, or study results you've requested regarding device performance.

    Therefore, I cannot provide the information requested in your prompt based on the provided text. The document confirms that the device is substantially equivalent to a predicate device for the stated indications for use, but it does not detail the underlying performance studies or acceptance criteria themselves.

    Without the actual study report or performance data, I cannot complete the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

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