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510(k) Data Aggregation

    K Number
    K253705

    Validate with FDA (Live)

    Date Cleared
    2026-03-16

    (112 days)

    Product Code
    Regulation Number
    862.3610
    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 is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, and Phencyclidine in human oral fluid at the cutoff concentrations listed below and their metabolites:

    TestCalibratorCutoff (ng/mL)
    Amphetamine (AMP)d-Amphetamine50
    Cocaine (COC)Benzoylecgonine20
    Marijuana (THC)Delta-9-Tetrahydrocannabinol40
    Methadone (MTD)Methadone30
    Methamphetamine (MET)d-Methamphetamine50
    Opiates (OPI)Morphine40
    Oxycodone (OXY)Oxycodone20
    Phencyclidine (PCP)Phencyclidine10

    The test provides only preliminary test results. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to distinguish between prescription use or abuse of the drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

    Device Description

    The Healgen® Accurate Oral Fluid Drug Test is a lateral flow chromatographic immunoassay for the qualitative detection of Amphetamine, Cocaine, marijuana, Methadone, Methamphetamine, Opiates, Oxycodone and Phencyclidine in oral fluids. 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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