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510(k) Data Aggregation

    K Number
    K033165
    Device Name
    PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2003-10-14

    (14 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K951595
    Why did this record match?
    Device Name :

    PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS

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

    The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

    The Cfas DAT Qualitative Amphetamine calibrator is designed for the qualitative calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

    Device Description

    Roche Preciset DAT Amphetamine calibrators contain 6 levels of amphetamines, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains six levels of amphetamines in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of amphetamines. The respective target concentrations of amphetamines included is as follows:

    Amphetamines: 0, 250, 500, 1000, 1500, 2000 ng/ml

    Roche Cfas DAT Qualitative Amphetamine calibrators contain a single level of amphetamines at a target concentration of 1000 ng/ml, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains 3 bottles of the single level amphetamines at 5 ml each.

    AI/ML Overview

    The provided text describes a 510(k) summary for Roche Preciset DAT Amphetamine and Cfas DAT Qualitative Amphetamine Calibrators. It details the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a performance study report.

    Therefore, I cannot provide the requested table and study details.

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