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510(k) Data Aggregation

    K Number
    K062942
    Device Name
    QUANTIMETRIX NICOSURE COTININE URINE CONTROL
    Manufacturer
    QUANTIMETRIX CORP.
    Date Cleared
    2006-10-30

    (32 days)

    Product Code
    LAS
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix NiCosure Cotinine Urine Control." It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. This letter signifies that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, which is a regulatory decision and not a performance study report.

    Therefore, I cannot provide the requested information from the given text.

    To answer your specific questions, I would need a document that describes the performance characteristics and validation study of the "Quantimetrix NiCosure Cotinine Urine Control," not just its regulatory clearance.

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