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510(k) Data Aggregation

    K Number
    K171403
    Device Name
    OralTox Oral Fluid Drug Test
    Manufacturer
    Premier Biotech Inc
    Date Cleared
    2018-02-02

    (266 days)

    Product Code
    DJC, DIO, DJG, DKZ, LCM, LDJ
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    Premier Biotech Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites: | Test | Calibrator | Cutoff (ng/mL) | |-----------------------|------------------------------|----------------| | Amphetamine (AMP) | d-Amphetamine | 50 | | Cocaine (COC) | Benzoylecgonine | 20 | | Marijuana (THC) | Delta-9 Tetrahydrocannabinol | 40 | | Methamphetamine (MET) | d-Methamphetamine | 40 | | Opiates (OPI) | Morphine | 40 | | Phencyclidine (PCP) | Phencyclidine | 10 | The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only.
    Device Description
    The OralTox Oral fluid Drug Test is immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Opiates and Phencyclidine (target analytes) 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.
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