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510(k) Data Aggregation

    K Number
    K073071
    Device Name
    EQ-PRC LC WARFARIN GENOTYPING KIT
    Manufacturer
    TRIMGEN CORPORATION
    Date Cleared
    2009-02-06

    (464 days)

    Product Code
    ODW, NSU, ODV
    Regulation Number
    862.3360
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIMGEN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eQ-PCR™ LC Warfarin Genotyping kit is an in vitro diagnostic test for the detection and genotyping of two single nucleotide polymorphisms (SNP) in the cytochrome P450 enzyme gene CYP2C9 known as CYP2C9*2 (C430T) and CYP2C9*3 (A1075C), and a SNP in the vitamin K epoxide reductase complex 1 gene VKORC1, known as VKORC1 (-1639G>A) obtained from human peripheral blood samples. The eQ-PCR LC Warfarin Genotyping kit is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The eO-PCR™ LC Warfarin Genotyping kit is indicated for use as an aid in identifying patients who may be at risk of warfarin sensitivity.
    Device Description
    The eQ-PCR 1M LC Warfarin Genotyping Kit assay requires extracted DNA obtained by using any commercially available DNA extraction kit. The extracted DNA sample, within a range of 50-200ng of total DNA, is mixed with a PCR Mix, and an eQ-PCR "M specific Probe Mix reagent containing specific primers and fluorescent labeled probes for the CYP2C9 and/or VKORC1 gene polymorphisms. Amplification and detection are then performed in the Roche Diagnostics LightCycler® Real-Time PCR System instrument model 1.2 using conditions defined in the specific eQ-PCRTM LC Warfarin Genotyping Kit Product Insert. After the PCR reaction is completed, the Roche Diagnostics LightCycler® Real-Time PCR System instrument automatically proceeds to the melting curve-based detection method. This real time PCR test is a closed test system and does not require post PCR operations. It reduces human errors and eliminates post-PCR handling contamination. The instrument's standard melting curve analysis software algorithm of peak patterns and melting temperatures (Tm) determine the genotype (wild type, mutant, heterozygous) for each of the three specified polymorphisms.
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