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510(k) Data Aggregation

    K Number
    K063186
    Device Name
    ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    2007-03-21

    (152 days)

    Product Code
    LFX
    Regulation Number
    866.3510
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM

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

    The Zeus Scientific, Inc. AtheNA Multi-Lyte Rubella IgG Test System is intended for the qualitative detection of IgG class antibody to Rubella virus in human sera by microparticle immunoassay testing on the AtheNA Multi-Lyte Instrument. The results of the AtheNA Multi-Lyte Rubella IgG Test System may be used to determine the serological status of individuals including women of childbearing age.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report. As such, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that you are requesting.

    The letter acknowledges that the device, "AtheNA Multi-Lyte Rubella IgG Test System," is substantially equivalent to a legally marketed predicate device for the qualitative detection of IgG class antibody to Rubella virus in human sera.

    Therefore, I cannot extract the information requested as it is not present in the provided text.

    To answer your questions, I would need access to the actual study report or relevant sections of the 510(k) submission that contain the performance data and methodology.

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