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510(k) Data Aggregation

    K Number
    K060417
    Device Name
    MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2006-03-21

    (32 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Type
    Special
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

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

    The Quantimetrix Corp. Drug of Abuse Urine Screen Control is intended to be used as a means of monitoring the performance of Abuscreen ONLINE, AxSYM, Triage and other drugs of abuse screening methods used for detecting drugs in unknown urine specimens.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix Drug of Abuse Urine Screen Control." It is a control material used for monitoring the performance of drug of abuse screening methods.

    Unfortunately, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results.

    The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It focuses on regulatory compliance and administrative details, not on a detailed scientific efficacy study report.

    Therefore, I cannot provide the requested information based on the input text.

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