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    K Number
    K103227
    Device Name
    ORATECT ORAL FLUID DRUG SCREEN DEVICES
    Manufacturer
    BRANAN MEDICAL CORPORATION
    Date Cleared
    2012-04-11

    (527 days)

    Product Code
    DIO,DIF,DJC,DJG,DKZ,LCM,LDJ
    Regulation Number
    862.3250
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K992918,K001197,K002375,K981341,K000399
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    Device Name :

    ORATECT ORAL FLUID DRUG SCREEN DEVICES

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

    The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.

    TestCutoff
    Oratect® Oral Fluid Drug Screen Device d-Amphetamine50 ng/mL
    Oratect® Oral Fluid Drug Screen Device d-Methamphetamine50 ng/mL
    Oratect® Oral Fluid Drug Screen Device Delta-9-Tetrahydrocannabinol40 ng/mL
    Oratect® Oral Fluid Drug Screen Device Cocaine20 ng/mL
    Oratect® Oral Fluid Drug Screen Device Morphine40 ng/mL
    Oratect® Oral Fluid Drug Screen Device Phencyclidine10 ng/mL

    These products are for in vitro diagnostic use and intended for prescription point of care use.

    The Orated® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect® Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

    OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.

    Device Description

    The Oratect® Oral Fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The test principle is a competitive lateral flow immunochromatographic assay. The presence of analyte will produce a negative signal.

    AI/ML Overview

    Acceptance Criteria and Device Performance for Oratect® Oral Fluid Drug Screen Devices

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the document consistently uses "Accuracy results against reference method >90%" as the performance metric for the subject device and "Accuracy results against reference method >89%" for the predicate. For the purpose of this summary, we will infer the acceptance criterion to be >90% accuracy against a reference method.

    The reported device performance based on the "Accuracy" row in the comparison table is also >90% against reference method.

    CharacteristicAcceptance Criteria (Inferred)Reported Device Performance
    Accuracy (against reference method)>90%>90%
    PrecisionNot explicitly stated, but predicate's
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