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510(k) Data Aggregation

    K Number
    K012483
    Device Name
    AMEDITECH IMMUTEST DRUG SCREEN OPIATES
    Manufacturer
    AMEDITECH, INC.
    Date Cleared
    2001-11-30

    (120 days)

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

    AMEDITECH IMMUTEST DRUG SCREEN OPIATES

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

    The Ameditech ImmuTest™ Drug Screen OPIATES is an In Vitro screen test for the qualitative detection of opiate metabolites in human urine at cut-off concentration of 2000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device called "Ameditech ImmuTest™ Drug Screen Opiates." This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    A 510(k) letter is an approval notification based on substantial equivalence to a legally marketed predicate device, not a detailing of the device's performance studies or clinical trial results. Therefore, I cannot extract the requested information from this document.

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