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    K Number
    K971620
    Device Name
    QUANTA LITE RUBEOLA (MEASLES) IGG
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-07-22

    (82 days)

    Product Code
    LJB
    Regulation Number
    866.3520
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE RUBEOLA (MEASLES) IGG

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

    The QUANTA Lite TM Rubeola (Measles) IgG ELISA System is designed for the qualitative determination of IgG antibodies to rubeola (measles) in human serum from adult, neonate, and immunocompromised patients. The test system is intended to be used to evaluate serologic evidence of previous infection with rubeola (measles) and as an aid in the diagnosis of rubeola (measles) infection.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain information regarding detailed acceptance criteria, study design parameters, or performance data beyond the device's intended use. Therefore, I cannot extract the specific information requested in the prompt based on the provided document.

    To answer your request, I would need a document that describes the premarket notification submission in detail, including the study protocols, results, and acceptance criteria.

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