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510(k) Data Aggregation

    K Number
    K223921
    Device Name
    Access CEA
    Manufacturer
    Beckman Coulter, Inc
    Date Cleared
    2023-09-22

    (267 days)

    Product Code
    DHX
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K991707,K981985
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

    Device Description

    The Access CEA assay is a two-site immunoenzymatic "sandwich" assay using two mouse monoclonal anti-CEA antibodies (MAb) which react with different epitopes of CEA. The Access CEA reagent kit is in a liguid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.

    AI/ML Overview

    The provided text describes the 510(k) submission for the Beckman Coulter Access CEA assay on the Dxl 9000 Access Immunoassay Analyzer. This document focuses on demonstrating substantial equivalence to a predicate device (Access CEA on the Access Immunoassay Analyzer), primarily through analytical performance studies rather than clinical or AI-assisted diagnostic studies.

    Therefore, many of the requested criteria related to AI performance, human reader studies, and expert ground truth are not applicable or cannot be extracted from this document. The information provided is characteristic of a submission for an in vitro diagnostic (IVD) device, which relies heavily on analytical performance characteristics.

    Here's the breakdown based on the provided text:

    1. Acceptance Criteria and Reported Device Performance

    The document provides acceptance criteria and performance for various analytical studies.

    Study TypeAcceptance CriteriaReported Device Performance
    Method ComparisonR² ≥ 0.90 and slope 1.00 ± 0.10N=153Concentration Range*: 0.46 - 1071 ng/mLSlope: 0.98Slope 95% Cl: 0.97 - 0.99Intercept: 0.058Intercept 95% Cl: 0.0015 - 0.17Correlation Coefficient R: 1.00The results met the acceptance criteria.
    Imprecision(Not explicitly stated in a single overall criterion, but implied to meet industry standards and internal acceptance limits, often expressed as %CV limits for different concentrations.) The acceptance is based on the presented %CV values being acceptable.Repeatability (Within-run): %CV range 1.8-3.5%Between-run: %CV range 0.8-2.5%Between-day: %CV range 1.2-3.1%Within-Laboratory (Total): %CV range 2.5-5.2%
    LinearityImplicitly, results should demonstrate linearity across the stated analytical measuring interval.The Access CEA assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of 0.2 - 1,000 ng/mL.
    Limit of Blank (LoB)Implicitly, the estimated LoB should be within acceptable limits (no specific numerical criterion given).The claimed LoB estimate for the Access CEA assay is 0.09 ng/mL.
    Limit of Detection (LoD)Implicitly, the estimated LoD should be within acceptable limits (no specific numerical criterion given).The claimed LoD estimate for the Access CEA assay is 0.1 ng/mL.
    Limit of Quantitation (LoQ)Implicitly, the claimed LoQ should be scientifically justified and within acceptable limits (no specific numerical criterion given).The claimed LoQ determined for Access CEA assay is 0.2 ng/mL.

    2. Sample size used for the test set and the data provenance:

    • Method Comparison: A total of 153 serum samples were evaluated.
    • Imprecision: Multiple samples (7 distinct concentration levels) were tested with a minimum of three replicates in 2 runs per day for a minimum of 20 days. The "N" column in the table refers to the total number of measurements for each sample level (e.g., 126 for Sample 1, 120 for Sample 2, etc.).
    • Data Provenance: The document does not specify the country of origin of the data or whether the samples were retrospective or prospective. This is typical for IVD analytical performance studies.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This information is not applicable to this type of device and study. The ground truth for analytical performance studies like Method Comparison, Imprecision, Linearity, LoB, LoD, and LoQ is established by the reference measurement method (in this case, the predicate device for method comparison, or precise measurements by the instrument itself for other analytical characteristics) and laboratory standards, not by expert human interpretation like a radiologist reading an image.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • This is not applicable. Adjudication methods are used in studies involving human interpretation or challenging diagnoses, not for analytical performance of an IVD assay measuring a biomarker concentration.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • This is not applicable. This is an in vitro diagnostic device (immunoassay for CEA), not an AI-powered image analysis or diagnostic assist device for human readers. No human interpretation or AI assistance study was performed or required for this type of submission.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • This is not applicable in the context of AI algorithms. The device itself (Access CEA assay on the Dxl 9000 Access Immunoassay Analyzer) is a standalone automated analytical instrument. Its performance is evaluated as an "algorithm only" in the sense that it performs the measurement independently, but it's a chemical and optical measurement process, not an AI algorithm.

    7. The type of ground truth used:

    • For the Method Comparison study, the "ground truth" or reference method was the predicate device (Access CEA on the Access Immunoassay Analyzer).
    • For other analytical studies (Imprecision, Linearity, LoB, LoD, LoQ), the ground truth is established through controlled spiking, dilutions, and repeated measurements according to established analytical validation guidelines (e.g., CLSI EP-05-A3 for imprecision). These are intrinsic analytical properties of the assay and instrument combination, verified against laboratory standards.

    8. The sample size for the training set:

    • This is not applicable as this is not an AI/machine learning device that requires a "training set" in the conventional sense. The development of an immunoassay involves optimizing reagents, antibodies, and instrument parameters, which is a different process from training a machine learning model.

    9. How the ground truth for the training set was established:

    • This is not applicable for the reasons stated in point 8.
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