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510(k) Data Aggregation

    K Number
    K252523

    Validate with FDA (Live)

    Date Cleared
    2026-02-12

    (185 days)

    Product Code
    Regulation Number
    862.3870
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Healgen® Accurate Oral Fluid Drug Test COT/THC is a lateral flow chromatographic immunoassay for the qualitative detection of cotinine (COT) and/or marijuana (THC) in oral fluid at the following cut-off concentrations:

    TestCalibratorCut-off (ng/mL)
    Cotinine (COT)(-) Cotinine30
    Marijuana (THC)Delta-9-Tetrahydrocannabinol40

    This test provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Liquid chromatography mass spectrometry (LC/MS) is the preferred method for the confirmation test.

    The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations listed below and their metabolites:

    TestCalibratorCut-off (ng/mL)
    Cotinine (COT)(-) Cotinine30
    Marijuana (THC)Delta-9-Tetrahydrocannabinol40

    This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.

    Device Description

    The Healgen® Accurate Oral Fluid Drug Test COT/THC and Healgen® Accurate Oral Fluid Drug Test are immunochromatographic assays that uses a lateral flow system for the qualitative detection of cotinine and marijuana in human oral fluid. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

    AI/ML Overview

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