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510(k) Data Aggregation

    K Number
    K180209
    Device Name
    Diazyme 1,5-AG Assay
    Manufacturer
    Diazyme Laboratories Inc.
    Date Cleared
    2018-10-04

    (253 days)

    Product Code
    NOZ
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    NOZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.
    Device Description
    Diazyme's 1.5-AG assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphoralated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate.
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    K Number
    K031604
    Device Name
    GLYCOMARK
    Manufacturer
    TOMEN AMERICA INC.
    Date Cleared
    2003-09-22

    (123 days)

    Product Code
    NOZ, JIS, JJX
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    NOZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.
    Device Description
    The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.
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