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510(k) Data Aggregation

    K Number
    K980865
    Device Name
    QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131
    Manufacturer
    PHAMATECH
    Date Cleared
    1998-04-01

    (26 days)

    Product Code
    DKZ,DIO,DJG,LAF,LCM,LDJ
    Regulation Number
    862.3100
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.

    Device Description

    QuickScreen™ Pro Multi Drug Screening Test

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (QuickScreen™ Pro Multi Drug Screening Test). It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

    However, this document does not contain the detailed acceptance criteria for the device's performance, nor does it include a description of the specific study that proves the device meets those criteria. It's a regulatory approval document, not a scientific study report or a summary of performance data.

    Therefore, I cannot extract the information you requested about acceptance criteria and study details from this document.

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