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510(k) Data Aggregation

    K Number
    K991505
    Device Name
    MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1999-08-05

    (98 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICRO-STRIP FOR PHENCYCLIDINE METABOLITES

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

    The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is an immunoassay that qualitatively detects the major Phencyclidine metabolites in urine at the SAMHSA cutoff level of 25 ng/m1. The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is intended for use by clinical toxicology labratories, physician offices, drug abuse clinics and law enforcement agencies only.

    Device Description

    Not Found

    AI/ML Overview

    I am unable to answer this question. The provided text is a 510(k) clearance letter from the FDA, which confirms that a device (MICRO-STRIP FOR PHENCYCLIDINE METABOLITES) is substantially equivalent to a legally marketed predicate device.

    However, this document does not contain any information about the acceptance criteria, study details, performance data, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for the device. It merely states that the device is cleared for marketing based on its substantial equivalence to a predicate.

    Therefore, I cannot extract the requested information from the provided text.

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