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    K Number
    K111527
    Device Name
    MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
    Manufacturer
    ERAGEN BIOSCIENCES, INC.
    Date Cleared
    2011-08-03

    (63 days)

    Product Code
    OQO,MAY
    Regulation Number
    866.3305
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERAGEN BIOSCIENCES, INC.

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

    The MultiCode® -RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.

    Warning: The device is not FDA cleared for the use with cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but I cannot answer your request based on the document you provided. The document primarily consists of an FDA clearance letter for the MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit, and it does not contain the detailed information about acceptance criteria, study methodologies, sample sizes, or ground truth establishment that you are requesting. It confirms the device's clearance and provides its indications for use, but it does not include the specifics of the performance study.

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