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    K Number
    K250073
    Device Name
    Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
    Manufacturer
    Tosoh Bioscience, Inc.
    Date Cleared
    2025-10-03

    (266 days)

    Product Code
    PDJ
    Regulation Number
    862.1373
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K200904
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood and hemolysate specimens using ion-exchange high performance liquid chromatography (HPLC).

    This test is to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

    Device Description

    The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood and hemolysate specimens using ion-exchange high performance liquid chromatography (HPLC). The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 analyzer is to be used in the clinical laboratory setting. The analyzer hemolyzes and dilutes whole blood specimens and subsequently injects the diluted and hemolyzed sample into the injection valve and onto the TSKgel GR01 HbA1c Column. Manually hemolyzed and prediluted samples can be loaded in sample cups directly for analysis on the analyzer. Separation of hemoglobin fractions is achieved by using differences in ionic interactions between the cation exchange group on the column resin surface and the hemoglobin components by a step gradient elution with three elution buffers of different ionic strengths. Changes in light absorbance at 415nm caused by hemoglobin fractions eluting from the column are monitored. The GR01 software has chromatographic peak retention time windows for the six expected hemoglobin fractions, A1a, A1b, HbF, LA1c+, SA1c, and A0. In addition, the software has retention time windows for the presumptive identification of the common hemoglobin variants, D, S, C, and E. An analysis requires 50 seconds per sample to complete. A printout of the results includes the sample ID, date, percentage, and retention time of each hemoglobin fraction, the SA1c percentage along with a chromatogram of the elution pattern of the hemoglobin fractions. The analyzer is equipped with external USB ports. These can be used to store assay results, to update and backup program versions, to attach an external device, for example an external printer or an optional handheld barcode scanner, and for software installation or backup of data. The last 150,000 assay results are automatically saved to the analyzer's internal memory and can be retrieved as list data in .CSV format and chromatograms in .PDF format.

    The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 system consists of the following components.

    • GR01 HbA1c Elution Buffer No. 1, No. 2, No. 3
    • TSKgel® GR01 HbA1c Column
    • Hemoglobin A1c Controls Levels 1 and 2
      • 21 CFR 862.1660, Product Code JJX
    • Hemoglobin A1c Calibrator Set
      • 21 CFR 862.1150, Product Code JIT
    • Hemolysis and Wash Solution (L) and (LL)
      • 21 CFR 864.8540, Product Code GGK
    AI/ML Overview

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