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The INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device intended for the quantitative determination of total topiramate in serum or heparinized plasma by fluorescence polarization immunoassay. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® (TDx or TDxFLx®) analyzer. The INNOFLUOR™ Topiramate Reagent Set is intended for the quantitative determination of total topiramate in serum or heparinized plasma. The reagent set is intended for use in the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Calibrator Set is intended for use in the calibration of the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Reagent Set and Calibrator Set are used together to generate the calibration curve on the TDx or TDxFLx® analyzer. The calibration curve must be established prior to assaying unknown samples. Prior to performing the calibration procedure, the correct analyzer operating parameters must be set by following the instructions provided in the Product Insert Supplement, which is included with every INNOFLUOR™ Topiramate Reagent Set. The INNOFLUOR™ Topiramate Control Set is intended for use in the quality control of the INNOFLUOR™ Topiramate Assay System. The Controls have been selected to best monitor the quality and stability of the calibration curve. The control results must be within established acceptable ranges before patient samples are assayed.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay for the quantitative determination of total topiramate in serum or heparinized plasma. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.