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510(k) Data Aggregation

    K Number
    K173909
    Device Name
    Dimension Hemoglobin A1c Assay
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2018-07-13

    (203 days)

    Product Code
    PDJ
    Regulation Number
    862.1373
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K160571
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    Device Name :

    Dimension Hemoglobin A1c Assay

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

    The Dimension® Hemoglobin A1c assay is an in vitro diagnostic assay for the quantitative determination of %HbA 1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood for use on the Dimension® clinical chemistry system. Measurement of Hemoglobin A1c is used as an aid in diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.

    Device Description

    The Dimension® Hemoglobin A1C assay is an in vitro diagnostic device intended to measure the concentration of hemoglobin A1c in venous human anticoagulated whole blood. The assay consists of three reagents packaged in Dimension® Flex® cartridges. The reagents are liquid and ready to use.

    AI/ML Overview

    The provided text describes the Siemens Healthcare Diagnostics Inc.'s Dimension® Hemoglobin A1c Assay, a Class II medical device for quantitative determination of %HbA1c and mmol/mol HbA1c in human anticoagulated venous whole blood. The document details studies undertaken to demonstrate the device's performance, primarily for a 510(k) premarket notification to show substantial equivalence to a predicate device.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" with numerical targets for each performance characteristic. Instead, it presents study results and, for some criteria, qualitative conclusions (e.g., "No significant interference," "No deviations from linearity"). The assessment of "substantial equivalence" to the predicate device implies that the reported performance meets acceptable clinical standards for HbA1c measurement.

    Performance MetricAcceptance Criteria (Implied / Qualitative)Reported Device Performance
    Method Comparison (against NGSP Reference Method)Agreement with NGSP reference method; low bias.Passing-Bablok: Slope [0.966 to 1.001], Y-int [-0.095 to 0.144] (%HbA1c); Bias at decision levels: -1.10% to -1.45% (%HbA1c)
    Deming: Slope [0.957 to 1.000], Y-int [-0.094 to 0.198] (%HbA1c); Bias at decision levels: -1.16% to -1.77% (%HbA1c)
    PrecisionLow variability (Repeatability, Between-Run, Between-Day, Between-Instrument, Between-Lot, Total CV).Total CV: 1.7% to 2.6% for %HbA1c (QC samples), 1.6% to 2.4% for %HbA1c (patient pools)
    Total ErrorAcceptable total error at decision levels.Ranged from 4.4% to 5.8% (%TE) for %HbA1c at various decision levels.
    Endogenous & Exogenous InterferenceNo significant interference (e.g.,
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