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510(k) Data Aggregation

    K Number
    K972526
    Device Name
    METHADONE EIA ASSAY
    Manufacturer
    DIAGNOSTIC REAGENTS, INC.
    Date Cleared
    1997-08-04

    (39 days)

    Product Code
    DJR
    Regulation Number
    862.3620
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    METHADONE EIA ASSAY

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

    This homogeneous methadone enzyme immunoassay is intended to be used for aualitative and semi-quantitative determination of methadone in human urine. The assay provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. (નેકડ chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification response letter from the FDA regarding a Methadone EIA Assay. This document does not describe the acceptance criteria for the device or the study that proves the device meets those criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.

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

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