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    K Number
    K162772
    Device Name
    ARIES GBS Assay
    Manufacturer
    LUMINEX CORPORATION
    Date Cleared
    2016-12-23

    (81 days)

    Product Code
    NJR,OOI
    Regulation Number
    866.3740
    Type
    Traditional
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    K152431
    Why did this record match?
    Device Name :

    ARIES GBS Assay

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

    The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal specimen swabs obtained from pregnant women.

    The ARIES GBS Assay is intended for use as a method for detection in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection.

    The ARIES GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

    Device Description

    Not Found

    AI/ML Overview

    This is a letter for the ARIES GBS Assay from the FDA and does not contain the information required to answer the question, as it is a device approval letter and not a study.

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