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510(k) Data Aggregation

    K Number
    K960913
    Device Name
    ACCESS FREE T3 ASSAY
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Date Cleared
    1996-03-29

    (23 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism.

    Device Description

    The ACCESS® Free T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free triiodothyronine in human serum.

    AI/ML Overview

    This document describes the regulatory submission for the ACCESS® Free T3 assay, an in vitro diagnostic device, not a device that utilizes AI or machine learning. Therefore, many of the requested categories (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

    Here's an analysis based on the provided text, focusing on the device's performance characteristics as an immunoassay:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryReported Device PerformanceComments from Document
    PrecisionWithin-run CV: 3.74% (high control) to 12.75% (low control)
    Total Imprecision CV: 5.08% (high control) to 13.42% (low control)Ranges for Coefficient of Variation (CV) are provided for different control levels (low and high).
    Correlation to Predicate Devicer = 0.929 (Pearson correlation coefficient)
    Equation: y = -1.09 + 1.33x (where y is ACCESS® Free T3 and x is Ciba Corning Magic® 1-Free T3)This indicates a strong positive correlation and a linear relationship between the new device and the predicate.
    Analytical Sensitivity0.30 pg/mLThis is defined as the lowest detectable level of Free T3 distinguishable from zero with 95% confidence.

    Note: The document does not explicitly state pre-defined "acceptance criteria" values (e.g., "r > 0.90 is acceptable"). Instead, it presents the results of the studies and concludes substantial equivalence based on these results.

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

    • Sample Size for Test Set: 217 samples were used for the correlation study comparing the ACCESS® Free T3 assay to the predicate device.
    • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It just states "217 samples."

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

    Not applicable. This is an in vitro diagnostic assay for quantitative measurement, not an AI device requiring expert interpretation for ground truth. The "ground truth" for the correlation study is the measurement obtained from the predicate device.

    4. Adjudication method for the test set

    Not applicable. This is an in vitro diagnostic assay. Measurements are quantitative, not subject to subjective adjudication in the way image interpretation might be.

    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 is an in vitro diagnostic assay, not an AI device intended to assist human readers.

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

    Not applicable. This is an in vitro diagnostic assay with a direct quantitative output, not an AI algorithm. Its "standalone" performance is described by its precision and analytical sensitivity.

    7. The type of ground truth used

    For the correlation study, the "ground truth" was essentially the measurements obtained from the predicate device (Ciba Corning Magic® 1-Free T3 assay), against which the new device's measurements were compared. For precision and analytical sensitivity, the ground truth is inherent to the assay's ability to measure known concentrations or differentiate from zero.

    8. The sample size for the training set

    Not applicable. This is a traditional immunoassay, not an AI/machine learning model that requires a "training set." The assay's parameters would have been developed through R&D, but not in the sense of an ML training set.

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

    Not applicable, for the same reasons as above.

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