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510(k) Data Aggregation

    K Number
    K974027
    Device Name
    AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
    Manufacturer
    ALFA BIOTECH (UK) LTD.
    Date Cleared
    1998-02-02

    (102 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

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

    The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.

    Device Description

    Fluorescent immunoassay reagents.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Alfa Biotech (UK) Ltd AuraFlex® FT3, an immunoassay for free triiodothyronine. Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Not specifiedCorrelation of 0.9 with an "Other FT3 assay," with the specific linear relationship: AuraFlex® FT3 = 0.93 * (Other FT3 assay) + 0.2 pg/ml (or 0.3 pmol/l).

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

    • Sample Size: 110 human serum samples.
    • Data Provenance: Not explicitly stated, but the submission is from Alfa Biotech (UK) Ltd, suggesting the study may have been conducted in the UK or with UK-sourced samples. The data type is retrospective as it refers to a "comparison study" that was "conducted."

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

    This information is not provided in the given text. The "ground truth" appears to be established by comparison to another existing FT3 assay, rather than expert consensus on individual samples.

    4. Adjudication Method for the Test Set

    This information is not provided in the given text.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. The study conducted was a comparison of a new immunoassay against an existing one, not a study involving human readers or AI assistance.

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

    Yes, this was a standalone study of the device (immunoassay) performance. There is no mention of human-in-the-loop performance or AI.

    7. The Type of Ground Truth Used

    The ground truth was established by comparison to the results of an "Other FT3 assay." This implies a reference method or legally marketed predicate device.

    8. The Sample Size for the Training Set

    This information is not provided in the given text. The text describes a "comparison study" of 110 samples, likely representing the test set for performance evaluation. There's no mention of a separate training set.

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

    Since no training set information is provided, how its ground truth was established is not applicable/not provided.

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