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510(k) Data Aggregation

    K Number
    K003359
    Device Name
    COLOSCREEN-ES
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2000-11-27

    (31 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K980671
    Device Name
    COLOSCREEN-ES
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    1998-05-12

    (81 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ColoScreen-ES is designed for the qualitative detection of fecal occult blood. It is an aid in the diagnosis of gastrointestinal disorders such as hemorrhoids, diverticulitis, fissures, colitis or colorectal cancer. The test can be used in mass health screens, doctors offices or hospitals.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes the FDA's 510(k) clearance for the ColoScreen-ES device, a qualitative test for fecal occult blood. However, it does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

    The document is a clearance letter, indicating that the device has been deemed substantially equivalent to a predicate device. It briefly mentions the intended use of the ColoScreen-ES as an aid in diagnosing gastrointestinal disorders and for mass health screens, doctor's offices, or hospitals.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance
    2. Sample size and data provenance for the test set
    3. Number and qualifications of experts for ground truth
    4. Adjudication method
    5. MRMC comparative effectiveness study results
    6. Standalone performance study results
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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