LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K123785
    Device Name
    DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
    Manufacturer
    DIAZYME LABORATORIES
    Date Cleared
    2013-06-07

    (179 days)

    Product Code
    DDR,JIT,JJX
    Regulation Number
    866.5680
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K061683,K973358
    Why did this record match?
    Device Name :

    DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET

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

    The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.

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

    The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.

    Device Description

    The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.

    AI/ML Overview

    The Diazyme Myoglobin Assay's acceptance criteria and performance are detailed across sections of the provided document. The study primarily relies on method comparison and precision evaluations to demonstrate substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance
    Method ComparisonHigh correlation (R² close to 1) and a slope close to 1 with an intercept close to 0 when compared to the predicate device.R² = 0.9855, Slope = 0.9526, Y-intercept = -4.2228. This is reported as correlating "well" with the predicate method.
    Precision - Within-Run CV%Not explicitly stated but generally expected to be low (e.g., typically
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1