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    K Number
    K102510
    Device Name
    DIMENSIONS HB1C KIT, MODEL DF105A
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2011-05-13

    (259 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K070452
    Why did this record match?
    Reference Devices :

    K070452

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

    The HB1C assay on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.

    The HB1C CAL is an in vitro diagnostic product for the calibration of the Hemoglobin A1c (HB1C) method on the Dimension® clinical chemistry system.

    Device Description

    The Dimension® HB1C kit contains Flex® reagent cartridges and calibrator. Each cartridge contains reagents used to measure total hemoglobin and hemoglobin A1 . The reagents are liquid and ready to use on the instrument. The calibrator in the kit is a five level lyophilized product. Each level is hydrated with 2.0ml, of reagent grade water. The lot matched reagents and calibrator product are for use on all models of the Dimension® clinical chemistry system.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state formal "acceptance criteria" in terms of predefined thresholds for statistical metrics (e.g., "slope must be between X and Y", "intercept must be between A and B"). Instead, the study aims to demonstrate "substantial equivalence" to a legally marketed predicate device (BIO-RAD Variant® II Hemoglobin A1c) through a method comparison. The reported device performance is presented as the results of this comparison.

    Metric (from Deming Regression)Acceptance Criteria (Implicit from Substantial Equivalence Goal)Reported Device Performance (Dimension® HB1C vs. BIO-RAD Variant® II)
    %HbA1c AnalysisDemonstrate substantial equivalence to predicate device.
    Intercept(No explicit numerical criteria stated, but expected to be close to 0)0.44 (95% CI: 0.12 - 0.75)
    Slope(No explicit numerical criteria stated, but expected to be close to 1)0.90 (95% CI: 0.85 - 0.94)
    mmol/mol AnalysisDemonstrate substantial equivalence to predicate device.
    Intercept(No explicit numerical criteria stated, but expected to be close to 0)2.17 (95% CI: -0.35 - 4.70)
    Slope(No explicit numerical criteria stated, but expected to be close to 1)0.90 (95% CI: 0.85 - 0.95)

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size:
      • For %HbA1c analysis: 124 human whole blood samples.
      • For mmol/mol analysis: 123 human whole blood samples.
      • Note: The document states "One hundred and twenty- six (126) human whole blood samples... ranging from 4.4 to 16.18 homo". It then indicates that 2 samples were excluded from the %HbA1c analysis and 3 from the mmol/mol analysis because they were "out of range by one or both of the methods".
    • Data Provenance: Human anticoagulated whole blood samples preserved with EDTA. The country of origin is not specified, and it is presented as a retrospective analysis of collected samples.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    Not applicable. This study is a method comparison against a predicate device, not a diagnostic accuracy study establishing ground truth through expert review.

    4. Adjudication Method for the Test Set

    Not applicable. No adjudication by experts was performed.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This is a comparison of two in vitro diagnostic (IVD) assays, not an AI-assisted diagnostic device involving human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Yes, in a sense. The study directly compares the results of the new device (Dimension® HB1C kit) with the predicate device (BIO-RAD Variant® II Hemoglobin A1c) without human intervention in the interpretation of the raw assay results. It’s a standalone device performance comparison for quantitative measurements.

    7. The Type of Ground Truth Used

    The "ground truth" in this context is the measurements obtained from the legally marketed predicate device, BIO-RAD Variant® II Hemoglobin A1c. The study aims to demonstrate that the new device produces results substantially equivalent to this established method. Both methods are certified by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT) and traceable to the IFCC reference method.

    8. The Sample Size for the Training Set

    Not applicable. This is an analytical method comparison study, not a machine learning model training.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. No training set or machine learning model is involved.

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