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510(k) Data Aggregation

    K Number
    K973153
    Device Name
    UBI MAGIWEL AMPHETAMINE METABOLITES
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1997-10-28

    (67 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UBI MAGIWEL AMPHETAMINE METABOLITES

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

    THE UBI MAGIWEL™ Amphetamine metabolites is a solid phase enzyme-linked immonosorbent assay(ELISA). This test provides a specific and sensitive assay to qualitatively detect the major amphetamine metabolites in human urine.

    Device Description

    solid phase enzyme-linked immonosorbent assay(ELISA)

    AI/ML Overview

    The provided text does not contain information on the acceptance criteria and study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the UBI MAGIWEL™ Amphetamine Metabolites device, indicating that it has been deemed substantially equivalent to a predicate device. It defines the device and its intended use but does not detail the performance study or specific acceptance criteria.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size, data provenance, number of experts, or adjudication method for a test set.
    3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    4. Information on a standalone performance study.
    5. The type of ground truth used.
    6. Sample size for the training set or how its ground truth was established.
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