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510(k) Data Aggregation

    K Number
    K980521
    Device Name
    DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
    Manufacturer
    BAYER CORP.
    Date Cleared
    1998-04-02

    (64 days)

    Product Code
    KXT
    Regulation Number
    862.3320
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This in vitro diagnostic procedure is intended to quantitatively measure the concentration of digoxin in human serum and plasma on the Technicon RA/opeRA systems. Measurements obtained with this procedure are used to monitor circulating levels of this drug so that proper therapeutic level is maintained while avoiding toxicity.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes the performance of the Technicon RAM and opeRA Chemistry Systems Digoxin (using Syva Emit 2000* Reagents) in comparison to a predicate device (Bayer Immuno 1 Digoxin method), submitted for 510(k) clearance by the FDA.

    Here's an analysis of the provided information based on your requested criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    The text doesn't explicitly state "acceptance criteria" but presents performance data for the new device (RA/opeRA) and the predicate device (Immuno 1) for comparison, implying that similar or better performance compared to the predicate is the expectation for clearance.

    MetricAcceptance Criteria (Implied by Predicate)Reported Device Performance (RA/opeRA)
    Minimum Det. Conc.0.04 ng/mL0.20 ng/mL
    Precision (Total)8.2% @ 0.7ng/mL4.2% @ 2.2ng/mL3.6% @ 3.4ng/mL20.0% @ 0.4ng/mL9.0% @ 1.3ng/mL9.0% @ 2.8ng/mL
    CorrelationRange of RA analyte concentration = 0.2 - 2.8 ng/mL (This is a range, not a direct criterion)y=1.08x+0.11
    where y=RA/opeRA, x=Immuno 1
    n=39
    r=0.949
    Syx=0.2 ng/mL

    Analysis of Performance vs. Implied Acceptance:

    • Minimum Detection Concentration: The RA/opeRA system has a higher minimum detection concentration (0.2 ng/mL) compared to the Immuno 1 (0.04 ng/mL), suggesting it is less sensitive at very low concentrations.
    • Precision: The RA/opeRA system shows worse precision (higher percentages) at all tested concentrations compared to the Immuno 1. For example, at its lowest tested concentration (0.4 ng/mL), it has 20.0% precision, whereas the Immuno 1 has 8.2% at 0.7 ng/mL.
    • Correlation: The correlation coefficient (r=0.949) between the RA/opeRA and Immuno 1 methods, with n=39 samples and a Syx (standard error of the estimate) of 0.2 ng/mL, indicates a strong positive linear relationship, but the slope (1.08) and y-intercept (0.11) suggest a slight systematic difference from perfect agreement (y=x). The range of analyte concentration for the RA method (0.2 - 2.8 ng/mL) is also provided.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: For the correlation study, n=39 samples were used.
    • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied the data was generated to support the 510(k) submission, likely in a controlled laboratory setting.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable. This is an in vitro diagnostic device measuring digoxin concentration using chemical reactions. The "ground truth" is established by the analytical measurement of the predicate device (Immuno 1), not by human experts interpreting images or clinical data.

    4. Adjudication Method for the Test Set

    Not applicable for an in vitro diagnostic device study of this nature. Ground truth is compared to a reference method, not adjudicated by experts in the typical sense.

    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

    Not applicable. This study concerns an in vitro diagnostic device, not an AI-assisted diagnostic tool that would be interpreted by human readers.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

    This is a standalone diagnostic device (RA/opeRA system) without human-in-the-loop AI interpretation. Its performance is measured as described in the table against a predicate device.

    7. The Type of Ground Truth Used

    The "ground truth" for this study is the measurements obtained from a legally marketed predicate device (Bayer Immuno 1 Digoxin method). This method serves as the reference against which the new device's performance is compared for substantial equivalence.

    8. The Sample Size for the Training Set

    The document does not provide information about a "training set" or its sample size. For in vitro diagnostic devices, development often involves extensive internal testing and optimization (which could be likened to training) but the 510(k) submission typically focuses on validation or comparison data.

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

    Not applicable, as no information on a distinct "training set" or its ground truth establishment is provided. Device development and calibration would typically involve a series of known concentration standards and controls, but these are not explicitly detailed as a "training set" within this summary.

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