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510(k) Data Aggregation

    K Number
    K102400
    Device Name
    SYPHILIS HEALTH CHECK
    Manufacturer
    DIAGNOSTICS DIRECT, LLC.
    Date Cleared
    2011-08-01

    (342 days)

    Product Code
    LIP
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTICS DIRECT, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Syphilis Health Check is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood, serum or plasma. This product can be used as an initial screening test or in conjunction with a non-treponemal laboratory test and clinical findings, may aid in the diagnosis of syphilis infection. This test is not intended for use in screening blood or plasma donors.
    Device Description
    SYPHILIS HEALTH CHECK is a rapid qualitative screening test for detection of human antibodies to TP in serum, plasma or whole blood. The method employs an unique combination of anti-human immunoglobulins gold conjugate and highly purified TP recombinant proteins to specifically detect anti-TP antibodies. The test mainly detects IgG and IgM will also react in case of high concentrations. As the samples flow through the absorbent device, the anti-human immunoglobulins/protein A dye conjugate binds to the human immunoglobulins forming an antigen-antibody complex. This complex binds to the recombinant protein in the positive reaction zone and produces a pink-rose colored band. In the absence of anti TP antibodies, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the reaction and control zones. Unbound conjugate binds to the reagents in the control zone producing a pink-rose color band, demonstrating that the reagents are functioning correctly.
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