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    K Number
    K242911
    Device Name
    Medconn Glycated Hemoglobin Test system
    Manufacturer
    Shanghai Medconn Medical Technology Co.,Ltd.
    Date Cleared
    2025-06-20

    (269 days)

    Product Code
    PDJ, LCP
    Regulation Number
    862.1373
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    Applicant Name (Manufacturer) :

    Shanghai Medconn Medical Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood or hemolysate with ion-exchange high performance liquid chromatography (HPLC) using the Medconn HbA1c Assay Kit (HPLC) on the Medconn Glycated Hemoglobin Analyzer, models MQ3000 and MQ3000PT. Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
    Device Description
    The Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human venous blood or hemolysate using ion-exchange high performance liquid chromatography (HPLC) on the Medconn Glycated Hemoglobin analyzer, models MQ-3000 and MQ-3000PT. A high-pressure pumping system delivers a buffer solution to an analytical cartridge and detector. Whole blood samples undergo an automatic hemolysis and dilution process before being introduced into the analytical flow path. Manually hemolyzed and prediluted samples loaded in sample cups at designated location are directly introduced for analysis. A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the flow cell where changes in the absorbance are measured at 415nm and recorded as a digital chromatogram. The software performs an analysis of the hemoglobin peaks in the chromatogram, recording information including retention time, peak area, and relative peak area of the detected substance over the total peak area of all substances. Peaks identified as target analytes are calibrated to generate a report and a chromatogram for each sample. Medconn Glycated Hemoglobin Test system contains the following components: - Medconn Glycated Hemoglobin analyzer - Medconn HbA1c Assay Kit (HPLC) - Medconn Hemoglobin A1c Calibrator - Medconn Hemoglobin A1c Control - Medconn HbA1c Column Kit (HPLC) - Medconn HbA1c Haemolyser
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