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510(k) Data Aggregation

    K Number
    K060351
    Device Name
    MEDTOX OXYCODONE
    Manufacturer
    MEDTOX DIAGNOSTICS, INC.
    Date Cleared
    2006-05-12

    (88 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K040411
    Why did this record match?
    Device Name :

    MEDTOX OXYCODONE

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

    The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription point-of-care use including physician office laboratories and central laboratory settings. It is also intended for workplace settings, criminal justice or forensic settings, and drug rehabilitation centers. MEDTOX® OXYCODONE is not for over-the-counter sale. The test detects oxycodone at concentrations 100 ng/mL and above. THE MEDTOX® OXYCODONE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT.

    Device Description

    Each test strip contains antibody colloidal gold, a drug conjugate and a control line. A mouse monoclonal antibody specific to oxycodone is mixed with colloidal gold and applied to the sample well pad of the strip. Drug is conjugated to protein and immobilized at the test line. Strips have an anti-mouse immunoglobulin antibody immobilized at the control line. The anti-mouse antibody binds the mouse antibody coated on the colloid gold, When urine is applied to the sample well of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strip carrying the red antibody-colloidal gold with it.

    AI/ML Overview

    MEDTOX® OXYCODONE Test System: Acceptance Criteria and Performance Study Summary

    This document describes the acceptance criteria and performance study results for the MEDTOX® OXYCODONE Test System, an immunochromatographic test strip for the rapid, qualitative detection of oxycodone in human urine. The information is extracted from the 510(k) summary K060351.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Implied)Reported Device Performance
    Precision/Reproducibility
    75% below cutoff (25 ng/mL)Consistent negative results100% negative results
    50% below cutoff (50 ng/mL)Majority negative results93% negative results
    At cutoff (100 ng/mL)Majority positive results (or clear distinction at cutoff)93% positive results
    25% above cutoff (125 ng/mL)Consistent positive results98% positive results
    50% above cutoff (150 ng/mL)Consistent positive results100% positive results
    Point-of-Care (POC) PrecisionSimilar performance to in-house professional study"Similar to the professional study" for most levels; consistent at 0 and 150 ng/mL
    **Analytical Specificity
    (Cross-Reactivity)**Oxycodone: Positive at 100 ng/mL (100% reactivity)
    Oxymorphone: Significant cross-reactivity expected (compared to predicate)
    Other opiates/compounds: Low or no cross-reactivityOxycodone: Positive at 100 ng/mL (100% reactivity)
    Oxymorphone: Positive at 200 ng/mL (50% reactivity)
    Codeine: Positive at 5,000 ng/mL (2%)
    Ethylmorphine: Positive at 5,000 ng/mL (2%)
    Dihydrocodeine: Positive at 10,000 ng/mL (1%)
    Hydrocodone: Positive at 75,000 ng/mL (
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