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510(k) Data Aggregation

    K Number
    K173206
    Device Name
    SEKURE HbA1c Assay
    Manufacturer
    Sekisui Diagnostics PEI Inc.
    Date Cleared
    2018-07-12

    (283 days)

    Product Code
    PDJ,LCP
    Regulation Number
    862.1373
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K103531
    Why did this record match?
    Device Name :

    SEKURE HbA1c Assay

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SEKURE HbA1c assay is used to measure the percent concentration of hemoglobin A1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate on the SK500 Clinical Chemistry System. Measurement of HbA 1c is used as an aid in the diagnosis of diabetes mellitus, as an aid in the identification of patients at risk for development of diabetes mellitus, and for the monitoring of long-term blood glucose with diabetes mellitus. For In Vitro Diagnostic Use Only.

    Device Description

    The SEKURE HbA1c assay is an enzymatic assay for the measurement of the percent hemoglobin A1c concentration. The assay consists of a pre-treatment hemolyzing buffer solution and two working reagents. Testing is performed on the SK500 K103531in conjunction with calibrators and controls which will be provided separately.

    AI/ML Overview

    The SEKURE HbA1c Assay is an in vitro diagnostic device used to measure the percentage concentration of hemoglobin A1c (HbA1c) in human venous whole blood and hemolysate. It's intended to aid in the diagnosis and monitoring of diabetes mellitus. The device's performance was evaluated through various non-clinical studies to demonstrate its substantial equivalence to a predicate device.

    1. Acceptance Criteria and Reported Device Performance

    Precision (NGSP Units, Whole Blood)

    TestAcceptance Criteria (NGSP Within-Laboratory %CV)Reported Performance (Total Precision %CV) (Range across samples)
    Precision (NGSP Units)≤ 2.5%0.8% - 1.6%
    Precision (IFCC Units)≤ 4.5%0.9% - 2.7%
    Linearity (NGSP)± 7% across 4.0 to 14.0 %HbA1cPass (linear across 4.0 to 14.0 %HbA1c)
    Linearity (IFCC)± 7% across 20.02 to 129.34 mmol/mol HbA1cPass (linear across 20.02 to 129.34 mmol/mol HbA1c)
    HbF InterferenceRelative % Difference
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