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510(k) Data Aggregation

    K Number
    K112120
    Device Name
    DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
    Manufacturer
    DIAZYME LABORATORIES
    Date Cleared
    2013-01-24

    (549 days)

    Product Code
    GHH,DAP,JIT
    Regulation Number
    864.7320
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    k062203
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    Device Name :

    DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET

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

    The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.

    The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

    The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

    Device Description

    Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Calibrator Set, and Diazyme D-Dimer Assay Control Set, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implicit from Predicate)Reported Device Performance (Diazyme D-Dimer Assay)
    Linear Range0.15 - 9 µg/mL FEU D-Dimer (Predicate: Roche Tina-Quant D-Dimer K062203)0.15 - 8 µg/mL FEU D-Dimer
    Precision (CV%)0.8 - 8.3% (Predicate: Roche Tina-Quant D-Dimer K062203)Internal Study:
    • Plasma Samples Within Run: 1.4% - 5.0%
    • Plasma Samples Total: 2.7% - 6.2%
    • Control Samples Within Run: 1.4% - 2.9%
    • Control Samples Total: 2.8% - 4.4%
      External Study:
    • Total CV%: 3.5% - 11.5% |
      | Correlation Coefficient (Method Comparison) | 0.775 (Predicate: vs. Asserachrom D-Dimer K862156) | 0.939 (vs. Roche Tina-Quant D-Dimer K062203) |
      | Slope (Method Comparison) | 1.03 (Predicate: vs. Asserachrom D-Dimer K862156) | 0.979 (vs. Roche Tina-Quant D-Dimer K062203) |
      | Intercept (Method Comparison) | -0.11 (Predicate: vs. Asserachrom D-Dimer K862156) | -0.106 (vs. Roche Tina-Quant D-Dimer K062203) |
      | Bias around medical decision point | Not explicitly stated for predicate in summary, but typical for method comparison studies. | -0.12 µg/mL FEU |
      | Limit of Blank (LOB) | Not explicitly stated for predicate. | 0.06 µg/mL FEU |
      | Limit of Detection (LOD) | Not explicitly stated for predicate. | 0.09 µg/mL FEU |
      | Limit of Quantitation (LOQ) | Not explicitly stated for predicate. | 0.15 µg/mL FEU (target CV
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