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    K Number
    K250249
    Device Name
    Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
    Manufacturer
    Gold Standard Diagnostics, LLC.
    Date Cleared
    2025-10-10

    (256 days)

    Product Code
    GMQ
    Regulation Number
    866.3820
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K150358
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is a non-treponemal flocculation test that can qualitatively determine the presence of reagin antibodies in human serum, automated on the AIX1000 Analyzer. It may be used to aid in the diagnosis of syphilis when used in conjunction with supplemental treponemal laboratory tests and other clinical information. This test may also be used to detect non-treponemal antibodies in samples serially diluted to establish titer information. This test is not intended for screening blood or tissue donors.

    Device Description

    The Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System in a non-treponemal test for the qualitative determination of reagin antibodies in human serum to aid in the diagnosis of syphilis. This test is also used to detect non-treponemal antibodies in samples serially diluted to establish titer information. The system consists of the Gold Standard Diagnostics RPR test reagents and the Gold Standard Diagnostics AIX1000 Agglutination Analyzer. The AIX1000 Analyzer delivers serum from collection tubes into test wells. After antigen suspension is added, the test wells are then incubated while being shaken. An onboard camera creates a high resolution image. The image is then analyzed by the proprietary software algorithm to produce a result.

    The RPR test reagents consist of a reactive control, a non-reactive control, and the antigen suspended in a carbon solution. When the antigen is mixed with sera, if antibodies are present, they will bind to the antigen and form black flocculants due to the presence of carbon particles. If no antibodies are present, then the carbon particles remain evenly distributed.

    The antigen used in the Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is a modified VDRL carbon antigen. The formulation is the same as that established by the Center for Disease Control (CDC)¹ containing 0.03% cardiolipin, 0.9% cholesterol, and 0.21% lecithin.

    The kit also includes untreated, 48 well reaction plates a reactive control and a non-reactive control.

    AI/ML Overview

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