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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
    Predicate For
    K091454,K130650
    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 (<1%) Hydromorphone: Positive at 50,000 ng/mL (<1%) Morphine: Positive at 50,000 ng/mL (<1%) Naloxone: Positive at 50,000 ng/mL (<1%) Norcodeine: Positive at 100,000 ng/mL (<1%) Many others: Negative at 50,000-100,000 ng/mL (<1%)
    pH InterferenceNo interference with results from pH values 4.0-9.0All pH levels (4.0-9.0) gave negative results at 25 ng/mL and positive results at 150 ng/mL
    Specific Gravity InterferenceNo interference with results from specific gravity 1.003-1.035All specific gravity levels (1.003-1.035) gave negative results at 25 ng/mL and positive results at 150 ng/mL
    Common Drugs InterferenceNo interference with results from common OTC/prescription drugsNone of the tested common drugs (e.g., Acetaminophen, Ibuprofen, Caffeine) affected expected results at 100 µg/mL
    Method Comparison (vs. GC/MS)High agreement with GC/MS for both positive and negative samples, particularly around the cutoff.Agreement among positives: 96% Agreement among negatives: 97%
    Comparison to Predicate DeviceEquivalent Indications for Use, ability to detect true negative and true positive samples, detect primary metabolite (oxymorphone), and limited cross-reactivity with other opiates.Equivalent Indications for Use. Ability to detect true negative samples (100%). Ability to detect true positive samples (+50% above cut-off) (98%). Cross-reactivity to oxymorphone (50% vs. 103% for predicate). Cross-reactivity to other opiate compounds (2% or less vs. <1% for predicate).

    2. Sample Size Used for the Test Set and Data Provenance

    • Precision/Reproducibility (Professional Study):
      • Sample Size: Drug-free urines spiked to 6 concentrations (0, 25, 50, 75, 100, 125, 150 ng/mL). Tested in triplicate on 6 different occasions, resulting in a total of 18 tests per concentration level. (The table shows "Number Tested" as 1, which appears to be a typo and likely refers to the number of panels or a mislabeling, given the description of triplicate testing on 6 occasions).
      • Data Provenance: Retrospective, conducted in-house by MEDTOX employees. Origin: likely USA (Burlington, NC is applicant's address).
    • Point-of-Care (POC) Precision:
      • Sample Size: 6 concentration levels (0, 25, 50, 100, 125, 150 ng/mL). Each operator tested 5 replicates per level. With 9 operators across 3 sites, this translates to 45 tests per concentration level per site (15/15/15 listed in the table is likely for the number of positive/negative results per site, not the total tested). Assuming 5 replicates, this would be 5 replicates * 3 sites * 3 operators = 45 tests per concentration. The table shows 15/15/15 under "Number Tested" for each site, implying 15 tests per concentration per site. So, 15 tests * 6 concentrations * 3 sites = 270 total tests.
      • Data Provenance: Prospective, conducted by 9 POC operators at 3 different sites. Origin: not explicitly stated beyond "POC sites," likely USA.
    • Analytical Specificity (Cross-Reactivity and Non-Reactive Compounds):
      • Sample Size: Each compound evaluated in triplicate. Total number of compounds not explicitly stated, but includes 19 cross-reactive compounds listed in the table and 11 non-cross-reactive endogenous compounds listed. An "extensive list" of unrelated compounds (prescription/OTC) was also evaluated.
      • Data Provenance: Retrospective, conducted by in-house operators. Origin: likely USA.
    • Interference (pH, Specific Gravity, Common Drugs):
      • Sample Size: Each condition (pH level, specific gravity level, common drug) evaluated in triplicate. pH: (6 levels * 3 replicates) * 2 concentrations = 36 tests. Specific Gravity: (8 levels * 3 replicates) * 2 concentrations = 48 tests. Common Drugs: Numerous drugs (14 listed) * 3 replicates * 2 concentrations (25% and 150% of cutoff) = 84 tests.
      • Data Provenance: Retrospective, conducted by in-house operators. Origin: likely USA.
    • Method Comparison (vs. GC/MS):
      • Sample Size: Total of (0+2+2+6+37) + (103+5+4+1+1) = 68 positive samples (by candidate device/GC/MS positive) + 114 negative samples (by candidate device/GC/MS negative) = 182 clinical urine samples.
      • Data Provenance: Retrospective clinical urine samples obtained from MEDTOX Laboratories. Screened using DRI Oxycodone 100 ng/mL cutoff Assay (predicate device) and confirmed by GC/MS for positive samples. Origin: likely USA.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    • Precision/Reproducibility: 3 MEDTOX employees who did not develop the test. Qualifications are not specified beyond being "MEDTOX employees." This was an internal study.
    • Point-of-Care (POC) Studies: 9 POC operators at 3 different sites. Qualifications are specified as individuals with "a minimum of a high school education who also satisfy specific training and certification guidelines" (demonstration of test, use of QA samples, proper technique, basic understanding of results, sample preparation for confirmation, review of training program, 80% on written exam).
    • Analytical Specificity and Interference Studies: In-house operators. Qualifications are not specified.
    • Method Comparison:
      • Ground Truth Establishment: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the ground truth. This is a highly accurate and generally accepted confirmatory method for drug testing.
      • Experts for GC/MS: The document doesn't explicitly state the number or qualifications of experts operating the GC/MS. However, GC/MS results are considered an objective and analytical gold standard, typically operated by trained analytical chemists or lab technicians specializing in toxicology.

    4. Adjudication Method for the Test Set

    • Precision/Reproducibility, Analytical Specificity, Interference: No explicit adjudication method described beyond raw results generated by the operators.
    • Method Comparison: No explicit adjudication method for the comparison between the candidate device and GC/MS. The comparison is direct against the GC/MS results, which serve as the reference standard. The results are presented as counts of agreement/disagreement with GC/MS.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

    No MRMC comparative effectiveness study was explicitly performed comparing human readers with AI vs. without AI assistance. This device is a rapid test strip intended for visual interpretation by trained operators, not an AI-assisted diagnostic tool.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    Yes, the precision, analytical specificity, and interference studies effectively represent standalone performance as the device's output (positive/negative line on the strip) is visually interpreted by the operator, but the inherent analytical performance of the strip itself is being evaluated under controlled conditions. The "Method Comparison" study also evaluates the standalone performance of the device against the GC/MS reference.

    7. The Type of Ground Truth Used

    • Precision/Reproducibility, Analytical Specificity, Interference: Spiked drug-free urine samples with known concentrations of oxycodone or interfering substances. This is a form of analytical truth (known concentration).
    • Method Comparison: GC/MS (Gas Chromatography/Mass Spectrometry) results. This is considered the gold standard analytical confirmatory method for drug detection.

    8. The Sample Size for the Training Set

    This submission does not describe a "training set" in the context of machine learning. The device is an immunochromatographic assay, not an AI/ML algorithm. The performance studies described are for validation of the ready-to-use device.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set in the context of AI/ML for this device.

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