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510(k) Data Aggregation

    K Number
    K252684

    Validate with FDA (Live)

    Device Name
    Labcorp Fentanyl Urine Visual Test
    Manufacturer
    Medtox Diagnostics, Inc.
    Date Cleared
    2026-01-29

    (157 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Age Range
    All
    Reference & Predicate Devices
    K232736
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Labcorp Fentanyl Urine Visual Test is a lateral flow competitive immunoassay for the rapid qualitative detection of norfentanyl (fentanyl metabolite) in human urine at a cutoff of 5 ng/mL. It is intended for prescription use. For in vitro diagnostic use only.

    This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. To confirm preliminary positive results, a more specific analytical method must be used. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods.

    Device Description

    The Labcorp Fentanyl Urine Visual Test (the "DEVICE") is a lateral flow competitive immunoassay for the rapid qualitative detection of Norfentanyl (nFEN), the primary urinary metabolite of Fentanyl, in human urine at concentrations above 5 ng/mL. It is intended for prescription use.

    The single use, in vitro diagnostic DEVICE is available in a cassette format with a disposable dropper provided for sample transfer.

    The DEVICE contains a test strip that gives a qualitative result for presence of Norfentanyl in human urine. The DEVICE is read visually and has labeling with instructions for interpreting test results.

    AI/ML Overview

    N/A

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