LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971441
    Device Name
    QUANTA LITE TOXOPLASMA IGG
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-12-02

    (228 days)

    Product Code
    LGD
    Regulation Number
    866.3780
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QUANTA Lite ™ Toxoplasma IgG ELISA System is designed for the semiine Quantitative determination of IgG antibodies to Toxoplasma gondii in human qualiticative accemination on as a be used to evaluate serologic evidence Serma. The esse off our and for in vitro diagnostic use. It can be used for prenatal screening for T. gondii IgG.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "QUANTA Lite™ Toxoplasma IgG ELISA Test Kit," indicating that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1