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    K Number
    K252749

    Validate with FDA (Live)

    Device Name
    Medconn 8K Glycated Hemoglobin Test System
    Manufacturer
    Shanghai Medconn Medical Technology Co., Ltd.
    Date Cleared
    2026-01-06

    (130 days)

    Product Code
    PDJ
    Regulation Number
    862.1373
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    K151321
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medconn 8K 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 8K HbA1c Assay Kit (HPLC) on the Medconn 8K Glycated Hemoglobin Analyzer, models MQ-8000 and MQ-8000PT.

    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 8K 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 8K Glycated Hemoglobin Analyzer, models MQ-8000 and MQ-8000PT.

    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 8K Glycated Hemoglobin Test System contains the following components:

    • Medconn 8K Glycated Hemoglobin Analyzer
    • Medconn 8K HbA1c Assay Kit (HPLC)
    • Medconn Hemoglobin A1c Calibrator
    • Medconn Hemoglobin A1c Control
    • Medconn 8K HbA1c Column Kit (HPLC)
    • Medconn HbA1c Haemolyser
    AI/ML Overview

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