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510(k) Data Aggregation

    K Number
    K971591
    Device Name
    INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
    Date Cleared
    1998-03-13

    (316 days)

    Product Code
    Regulation Number
    866.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAVID C. BISHOP, PH.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The INDX" Dip-S-Ticks scrub typhus test is an enzyme immunoassay for use as an aid in the diagnosis of scrub typhus, and detects total IgG and IgM antibodies to Orientia tsursugamushi. The Dip-S-Ticks test is qualitative when used to test a single specimen; when using paired specimens to detect sero-conversion the test may be semi-quantitative. The test is intended for use in serum as well as heparinized plasma, whole blood and finger-stick capillary blood and is intended to be performed by trained medical personnel only.
    Device Description
    The INDX® DIP-S-TICKS® Scrub Typhus Test For the Detection of IgG and IgM Antibodies to Orientia tsutsugamushi (scrub typhus) utilizes an enzyme-linked immunoassay (ELISA) dotblot technique for the detection of IgM as well as total (IgM and IgG) dengue antibodies. The antigen is dispensed as discrete dots onto a solid membrane. After adding specimen to a reaction vessel, an assay strip is inserted, allowing patient antibodies reactive with the test antigen to bind to the strip's solid support membrane. In the second stage, the reaction is enhanced by removal of non-specifically bound materials. During the third stage, alkaline phosphatase-conjugated anti-human IgG/IgM antibodies are allowed to react with bound patient antibodies. Finally, the strip is transferred to enzyme substrate reagent, which reacts with bound alkaline phosphatase to produce an easily seen, distinct spot.
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