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    K Number
    K994439
    Device Name
    ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2000-01-14

    (22 days)

    Product Code
    JHX
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306

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

    The AccEss® CK-MB assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.

    Device Description

    The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay Systems. The Access CK-MB reagents consist of reagent packs, calibrators, controls substrate and wash buffer. The Access CK-MB assay, CK-MB calibrators, CK-MB QC along with the Access System Wash Buffer and Substrate are designed for use with the Access Immunoassay Analyzer in a clinical laboratory setting.

    AI/ML Overview

    The provided document describes the Access® CK-MB Reagents on the Access® Immunoassay System, an in vitro diagnostic device for quantitative determination of CK-MB levels. The studies presented focus on the device's analytical performance rather than a comparative effectiveness study with human readers or a standalone clinical performance study.

    Here's an analysis of the acceptance criteria and study findings based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance
    PrecisionCV 0.95) and acceptable slope/intercept for equivalencen=356, r=0.984, y=0.836x + 0.662
    Correlation (Serum vs. Plasma - EDTA)High correlation (e.g., r > 0.95) and acceptable slope/intercept for equivalencen=48, r=0.998, y=1.009x + 1.119
    Correlation (Serum vs. Plasma - Heparin)High correlation (e.g., r > 0.95) and acceptable slope/intercept for equivalencen=84, r=0.999, y=1.015x - 0.631
    Analytical SensitivityLowest detectable level for zero with 95% confidence0.3 ng/ml

    Study Details

    1. Sample Sizes and Data Provenance:

      • Precision: Not explicitly stated, but typically involves repeated measurements of control samples.
      • Spiking and Dilution Recovery: One human sample containing CK-MB was used.
      • Correlation (Predicate Device): n=356 samples. Provenance (country of origin, retrospective/prospective) is not specified.
      • Correlation (Serum vs. Plasma - EDTA): n=48 paired samples. Provenance is not specified.
      • Correlation (Serum vs. Plasma - Heparin): n=84 paired samples. Provenance is not specified.
      • Analytical Sensitivity: Not explicitly stated, but uses the CK-MB S0 calibrator.

    2. Number of Experts and Qualifications for Ground Truth: Not applicable. This study focuses on analytical performance of an in vitro diagnostic device, not on interpretation by human experts.

    3. Adjudication Method: Not applicable. This study involves quantitative measurements by an automated system, not subjective interpretation requiring adjudication.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The document does not describe human readers or AI assistance.

    5. Standalone (Algorithm Only) Performance: Yes, the described studies represent the standalone performance of the Access® CK-MB assay when used on the Access® Immunoassay Analyzer. The studies evaluate the analytical capabilities of the device itself.

    6. Type of Ground Truth Used:

      • For Precision, Spiking, Dilution Recovery, and Analytical Sensitivity, the "ground truth" is based on the known or expected values of the control materials, spiked samples, and calibrators used in the analytical tests.
      • For Correlation studies, the "ground truth" is the measurements obtained from the predicate device (for the comparison with predicate) or the matched serum/plasma samples (for the plasma comparison).

    7. Sample Size for the Training Set: Not applicable. This document describes the validation of a laboratory assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves internal calibration and quality control procedures performed during manufacturing and prior to use.

    8. How Ground Truth for the Training Set Was Established: Not applicable, as there's no "training set" in the context of an AI/ML algorithm. For an IVD, the closest equivalent to "establishing ground truth for training" would be the rigorous characterization and validation of the calibrators, controls, and reagents used by the system as part of its development and manufacturing process. These are typically established through primary reference methods, certified reference materials, and extensive in-house validation.

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