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510(k) Data Aggregation

    K Number
    K060176
    Device Name
    EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    2006-02-07

    (15 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Special
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EL-ACL SCREEN; EL-ACL IGM, IGG, IGA

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

    The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text describes a 510(k) premarket notification for an in vitro diagnostic test (TheraTest EL-aCL™ screen and TheraTest EL-aCL™ IgM, IgG, IgA). This document is a regulatory approval letter from the FDA.

    This type of device is a laboratory assay, not an AI/ML powered device, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to AI-powered medical devices (like those involving image analysis, decision support systems, etc.) are not directly relevant in the way you've framed the request with terms like "test set," "ground truth," "MRMC study," and "training set."

    The document does not contain the information needed to fill out your request, as it does not describe an AI/ML algorithm or its development and validation.

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