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510(k) Data Aggregation

    K Number
    K163418
    Device Name
    Diazyme DZ-Lite Total beta-hCG Test System
    Manufacturer
    Diazyme Laboratories
    Date Cleared
    2017-08-18

    (255 days)

    Product Code
    DHA
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Diazyme DZ-Lite Total beta-hCG Test System

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA letter (K163418 regarding the Diazyme DZ-Lite Total BhCG Test System) describes the regulatory approval of a medical diagnostic device, specifically a human chorionic gonadotropin (HCG) test system.

    This type of document does not contain the detailed acceptance criteria and study data for an AI-powered medical device. The information requested in your prompt (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are specific to the development and validation of AI/ML-based diagnostic tools, particularly those involving image analysis or complex algorithmic interpretations.

    The FDA letter focuses on the substantial equivalence of the Diazyme BhCG test system to existing predicate devices under 21 CFR 862.1155, which is a different regulatory pathway and does not involve AI/ML performance evaluation as described in your prompt.

    Therefore, I cannot extract the requested information from the provided text because it is not present.

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