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    K Number
    K983895
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    1998-11-25

    (22 days)

    Product Code
    JZG
    Regulation Number
    866.5630
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K940353
    Why did this record match?
    Device Name :

    IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT

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

    The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.

    Device Description

    The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent, based on the provided text:

    Acceptance Criteria and Device Performance

    The provided document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data for a method comparison study and an imprecision study to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the device performs comparably to the predicate device and exhibits acceptable imprecision for its intended use.

    Here's a table summarizing the reported device performance, with the understanding that these are the results that presumably met the underlying (unspecified) acceptance criteria for substantial equivalence:

    Performance MetricReported Device Performance (IMMAGE B2MX Reagent)Implied Acceptance Criteria (relative to Predicate)
    Method Comparison (vs. Array 360 Beta-2-Microglobulin)Linear regression should demonstrate high correlation and agreement.
    Slope0.979Close to 1.0
    Intercept (mg/dL)-0.017Close to 0.0
    Correlation Coefficient (r)0.996Close to 1.0 (indicating strong correlation)
    Imprecision (Within-Run)CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance.
    Level 1 (0.10 mg/dL)10.0 %C.V.Acceptable for low concentrations
    Level 2 (1.84 mg/dL)2.3 %C.V.Low %C.V.
    Level 3 (3.19 mg/dL)1.9 %C.V.Low %C.V.
    Imprecision (Total)CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance.
    Level 1 (0.10 mg/dL)10.0 %C.V.Acceptable for low concentrations
    Level 2 (1.84 mg/dL)2.6 %C.V.Low %C.V.
    Level 3 (3.19 mg/dL)2.2 %C.V.Low %C.V.

    Study Details

    The provided document describes two main studies: a method comparison study and an imprecision study.

    2. Sample Size and Data Provenance

    • Test Set Sample Size (Method Comparison): 111 samples (for serum analytes)
    • Data Provenance: Not explicitly stated, but clinical laboratory device studies for FDA submission typically use samples from a clinical population. The document does not specify country of origin or whether samples were retrospective or prospective.

    3. Number of Experts and Qualifications for Ground Truth

    • Not Applicable. For this type of in vitro diagnostic device (IVD) studying an analyte's quantitative determination, ground truth is established by a reference method (the predicate device in this case) and traceable calibrators, not by expert interpretation.

    4. Adjudication Method

    • Not Applicable. No human interpretation or adjudication process is mentioned, as the study is a quantitative comparison of analytical methods.

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

    • No. An MRMC study is not relevant for this type of IVD, which quantifies a biomarker. MRMC studies are typically used for imaging diagnostics or other modalities requiring human interpretation.

    6. Standalone Performance (Algorithm Only)

    • Yes. The studies present the analytical performance of the IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent as a standalone system. The results (slope, intercept, correlation, imprecision) directly reflect the algorithm's (reagent and instrument's) ability to measure the analyte without human interpretation in the results generation process.

    7. Type of Ground Truth Used (Test Set)

    • Reference Method / Predicate Device Output. The "ground truth" for the method comparison study was the results obtained from the predicate device, the Beckman Array® Beta-2-Microglobulin (B2M) on the Array 360 system.

    8. Sample Size for Training Set

    • Not explicitly stated/Not applicable in the same way as AI/ML. For IVD assay development, there isn't a "training set" in the machine learning sense. Instead, development involves experiments to optimize reagent formulation, calibration curves, and instrument parameters, which effectively "train" the assay to measure accurately. The document does not provide details on the number of samples used during this development/optimization phase.

    9. How Ground Truth for Training Set Was Established

    • Not applicable in the same way as AI/ML. For IVD assays, the "ground truth" during development is established through the use of characterized reference materials, calibrators with known concentrations, and comparison to established reference methods or primary standards, ensuring traceability and accuracy. The document does not detail this process but it is standard for IVD development.
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