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510(k) Data Aggregation

    K Number
    K062096
    Device Name
    KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
    Manufacturer
    KOREAMEDICO CO. LTD.
    Date Cleared
    2007-05-07

    (287 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    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 Chextic is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary from the FDA for a pregnancy test, not a study describing the acceptance criteria and performance of a device with AI components. Therefore, the document does not contain the information requested in the prompt regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth establishment.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study with AI.
    6. Standalone algorithm performance.
    7. Type of ground truth used (expert consensus, pathology, outcomes data).
    8. Sample size for the training set.
    9. Method for establishing ground truth for the training set.

    The document is a regulatory approval letter for a traditional in-vitro diagnostic device (a urine pregnancy test), and thus does not involve AI, statistical studies for AI performance, or detailed clinical trial information in the format requested.

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