LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100144
    Device Name
    THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
    Manufacturer
    MICROGENICS CORP.
    Date Cleared
    2011-02-11

    (388 days)

    Product Code
    OUF,DLJ,LAS
    Regulation Number
    862.3840
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K034069
    Why did this record match?
    Reference Devices :

    K034069

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

    The QMS® Everolimus assay is intended for the quantitative determination of everolimus, the active ingredient of Zortress®, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

    The QMS Everolimus Calibrators set is intended for use in calibration of the QMS Everolimus Assay.

    The QMS® Everolimus Controls set is intended for use in quality control of the QMS® Everolimus Assay.

    Device Description

    The QMS® Everolimus Assay system is a homogeneous assay utilizing particle agglutination technology and competitive binding principles.

    AI/ML Overview

    The acceptance criteria and study proving device performance are detailed below:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test TypeAcceptance CriteriaReported Device Performance
    Functional Sensitivity (LOQ)Not explicitly stated as a numerical threshold in the provided text.The QMS Everolimus Assay Functional Sentivity results in a C.V. of 20%. The claimed LOQ is 2.0 ng/mL.
    PrecisionTotal run %CV less than or equal to 15.0%.In the study, the total run %CV was less than or equal to 15.0%.
    Method ComparisonNot explicitly stated as a numerical threshold (e.g., specific correlation coefficient).Samples were tested in the Everolimus Assay and compared to LC/MS. The method comparison exhibited correlated well with LC/MS as follows: System 1 = 0.93x + 0.03 R2 = 0.94; System 2 = 1.00x - 0.08 R2 = 0.95.
    Dilution Recovery (Linearity)Not explicitly stated as a numerical threshold for recovery or linearity.Results showed that the assay performs in a linear fashion.
    On-Board Open Vial Reagent StabilityReagents are stable for up to 30 days when stored on the analyzer.Reagents stored on the analyzer are stable for up to 30 days.

    2. Sample Size and Data Provenance

    • Test Set Sample Size: The document does not explicitly state the specific number of samples used for each performance test (e.g., Functional Sensitivity, Precision, Method Comparison, Dilution Recovery, Stability). For Method Comparison, it mentions "Samples were tested in the Everolimus Assay and compared to LC/MS."
    • Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

    3. Number and Qualifications of Experts for Ground Truth

    • This information is not provided. The ground truth for comparative studies (e.g., Method Comparison) was established using LC/MS, which is an analytical method rather than relying on human expert consensus.

    4. Adjudication Method

    • Not applicable as the ground truth for the Method Comparison was LC/MS, an analytical technique, not expert consensus requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic assay, and its performance is evaluated against reference analytical methods (like LC/MS) or established precision protocols, not against human reader performance.

    6. Standalone Performance Study

    • Yes, a standalone performance study was done for the algorithm (assay). The performance metrics like Functional Sensitivity, Precision, Method Comparison, Dilution Recovery, and Stability are all assessments of the device's standalone analytical performance.

    7. Type of Ground Truth Used

    • For the Method Comparison study, the ground truth was LC/MS (Liquid Chromatography/Mass Spectrometry), which is a gold standard analytical method for quantifying Everolimus in biological samples.

    8. Sample Size for the Training Set

    • This information is not provided. The document describes an assay system, not a machine learning algorithm that requires a separate "training set" in the conventional sense. The "calibration" of the assay refers to establishing a standard curve with known concentrations, but the sample size for developing this calibration is not specified.

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

    • For the assay's calibration (which can be considered analogous to training in a general sense for an analytical device), the QMS® Everolimus Assay's calibrators are "Traceable to calibration based on minimization of bias between the QMS assay and an LCMSMS assay for a specified adult renal transplant sample set." This means the ground truth for these calibrators was established by comparing them to results from an LC/MS/MS assay using a specific set of clinical samples.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1