LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K203564
    Device Name
    SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
    Manufacturer
    Immunalysis Corporation
    Date Cleared
    2021-12-22

    (380 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K183048,K200801,K101754
    Predicate For
    K252520
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For In Vitro Diagnostic Use.

    The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of oxycodone in human oral fluid with clinical analyzers. This assay is calibrated against oxycodone.

    The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

    The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.

    Device Description

    The SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is an in vitro test to detect the presence of oxycodone in human oral fluid samples collected by Quantisal II Oral Fluid Collection Device.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance CharacteristicAcceptance Criteria (Implied)Reported Device Performance
    Precision (Qualitative Mode) - QuantisalConsistently identify negative samples below cutoff and positive samples above cutoff, with mixed results around cutoff.At -100%, -75%, -50%, -25% of cutoff (0, 7.5, 15, 22.5 ng/mL): All 60 determinations were Negative. At Cutoff (30 ng/mL): 31 Negative / 29 Positive. At +25%, +50%, +75%, +100% of cutoff (37.5, 45, 52.5, 60 ng/mL): All 60 determinations were Positive.
    Precision (Semi-Quantitative Mode) - QuantisalMean concentrations should be close to expected values, with consistent negative/positive calls.At -100% (0 ng/mL): Mean Conc. -0.2 ng/mL, 60 Negative.At -50% (15 ng/mL): Mean Conc. 16.7 ng/mL, 60 Negative.At -25% (22.5 ng/mL): Mean Conc. 24.3 ng/mL, 60 Negative.At Cutoff (30 ng/mL): Mean Conc. 32.3 ng/mL, 16 Negative / 44 Positive.At +25% (37.5 ng/mL): Mean Conc. 42.1 ng/mL, 60 Positive.At +50% (45 ng/mL): Mean Conc. 53.3 ng/mL, 60 Positive.At +75% (52.5 ng/mL): Mean Conc. 64.3 ng/mL, 60 Positive.At +100% (60 ng/mL): Mean Conc. 76.3 ng/mL, 60 Positive.
    Precision (Qualitative Mode) - Quantisal II Pad AConsistently identify negative samples below cutoff and positive samples above cutoff, with mixed results around cutoff.At -100%, -75%, -50%, -25% of cutoff (0, 7.5, 15, 22.5 ng/mL): All 60 determinations were Negative. At Cutoff (30 ng/mL): 31 Negative / 29 Positive. At +25%, +50%, +75%, +100% of cutoff (37.5, 45, 52.5, 60 ng/mL): All 60 determinations were Positive.
    Precision (Semi-Quantitative Mode) - Quantisal II Pad AMean concentrations should be close to expected values, with consistent negative/positive calls.At -100% (0 ng/mL): Mean Conc. 0.5 ng/mL, 60 Negative.At -75% (7.5 ng/mL): Mean Conc. 7.3 ng/mL, 60 Negative.At -50% (15 ng/mL): Mean Conc. 14.7 ng/mL, 60 Negative.At -25% (22.5 ng/mL): Mean Conc. 21.7 ng/mL, 60 Negative.At Cutoff (30 ng/mL): Mean Conc. 29.9 ng/mL, 36 Negative / 24 Positive.At +25% (37.5 ng/mL): Mean Conc. 42.4 ng/mL, 60 Positive.At +50% (45 ng/mL): Mean Conc. 50.9 ng/mL, 60 Positive.At +75% (52.5 ng/mL): Mean Conc. 57.3 ng/mL, 60 Positive.At +100% (60 ng/mL): Mean Conc. 66.5 ng/mL, 60 Positive.
    Precision (Qualitative Mode) - Quantisal II Pad BConsistently identify negative samples below cutoff and positive samples above cutoff, with mixed results around cutoff.At -100%, -75%, -50%, -25% of cutoff (0, 7.5, 15, 22.5 ng/mL): All 60 determinations were Negative. At Cutoff (30 ng/mL): 28 Negative / 32 Positive. At +25%, +50%, +75%, +100% of cutoff (37.5, 45, 52.5, 60 ng/mL): All 60 determinations were Positive.
    Precision (Semi-Quantitative Mode) - Quantisal II Pad BMean concentrations should be close to expected values, with consistent negative/positive calls.At -100% (0 ng/mL): Mean Conc. 0.3 ng/mL, 60 Negative.At -75% (7.5 ng/mL): Mean Conc. 7.0 ng/mL, 60 Negative.At -50% (15 ng/mL): Mean Conc. 14.9 ng/mL, 60 Negative.At -25% (22.5 ng/mL): Mean Conc. 22.7 ng/mL, 60 Negative.At Cutoff (30 ng/mL): Mean Conc. 30.8 ng/mL, 28 Negative / 32 Positive.At +25% (37.5 ng/mL): Mean Conc. 42.9 ng/mL, 60 Positive.At +50% (45 ng/mL): Mean Conc. 49.4 ng/mL, 60 Positive.At +75% (52.5 ng/mL): Mean Conc. 58.3 ng/mL, 60 Positive.At +100% (60 ng/mL): Mean Conc. 67.1 ng/mL, 60 Positive.
    Specificity and Cross-ReactivityMinimal or no cross-reactivity with structurally similar compounds at high concentrations, and significant cross-reactivity with known related compounds.No/Minimal Cross-Reactivity (<0.08% at 40,000 ng/mL): 6-acetylcodeine, 6-acetylmorphine, Buprenorphine, Codeine, Desomorphine, Dihydrocodeine, Ethylmorphine, Fentanyl, Heroin, Hydrocodone, Hydromorphone, Levorphanol, Meperidine, Morphine, Morphine-3-B-D-glucuronide, Morphine-6-B-D-glucuronide, Naltrexone, Norbuprenorphine, Norcodeine, Normorphine, Tapentadol, Tramadol.Significant Cross-Reactivity: Naloxone (0.5% at 6,000 ng/mL), Noroxycodone (0.6% at 4,750 ng/mL), Noroxymorphone (0.2% at 12,500 ng/mL), Oxymorphone (85.7% at 35 ng/mL), Oxymorphone-3-β-D-glucuronide (5.5% at 550 ng/mL).
    Interference - Structurally Unrelated CompoundsNo interference observed for a wide range of common compounds.No interference observed with 89 common drugs and substances at concentrations up to 40,000 ng/mL (20,000 ng/mL for Chlorpromazine). (See Table 9 for complete list).
    Interference - Endogenous CompoundsNo interference observed for common endogenous substances.No interference observed with common endogenous compounds at tested concentrations (e.g., Ascorbic Acid: 3 mg/mL, Bilirubin: 0.15 mg/mL, Hemoglobin: 3 mg/mL). (See Table 10).
    Interference - Exogenous Compounds (Oral Fluid Samples)No interference observed for common exogenous substances and orally used products.No interference observed with common exogenous compounds (e.g., Acetaminophen: 0.1 mg/mL, Ibuprofen: 0.1 mg/mL, Alcohol: 6% v/v, Caffeine: 0.1 mg/mL) (See Table 11). No interference observed with orally used products (e.g., Teeth Whitener, Cigarette, Hard Candy, Chewing Gum, Hydrogen Peroxide, Sugar, Cough Syrup). (See Table 12).
    Interference - pHNo interference observed across a broad pH range.No interference observed for pH values ranging from 3.0 to 11.0.
    Linearity/RecoveryLinear range confirmed with acceptable drug recovery percentage.Linear range confirmed to be 10-110 ng/mL with drug recovery percentage from 90.6% to 111.6% across different collection devices. (See Tables 13, 14, 15).
    Oxycodone Stability in Oral FluidStability for a specified duration at recommended storage conditions.Oral fluid samples containing oxycodone are stable for up to 12 months at 2°C - 8°C in Quantisal II Oral Fluid Collection Device. Data for 10-day stability at ambient temperature (8°C - 25°C) in Quantisal II was referenced from K183048 and K200801.
    Calibration DurationMaintains performance over a specified calibration interval.Test results met acceptance criteria up to 24 days. Recommended frequency of calibration is 14 days.
    Method ComparisonGreater than 95% agreement with confirmatory method (LC-MS/MS).Achieved 100% agreement (40/40 positive and 40/40 negative) in both qualitative and semi-quantitative modes for Quantisal, Quantisal II "A", and Quantisal II "B" when compared to LC-MS/MS. (See Tables 16, 17, 18).

    2. Sample size used for the test set and the data provenance:

    • Precision Studies:

      • For Quantisal: 60 determinations (15 days, 2 runs/day, 2 collection devices/run, 1 replicate/device).
      • For Quantisal II Pad A: 60 determinations (same as above).
      • For Quantisal II Pad B: 60 determinations (same as above).
      • An additional 20-day study was performed (implied to be similar sample size) to demonstrate repeatability across 3 reagent lots.
      • Data Provenance: The samples were "spiked into drug free negative oral fluid." This indicates a laboratory-prepared, retrospective approach using controlled samples. The document does not specify the country of origin, but the company (Immunalysis Corporation) is based in Pomona, California, USA.

    • Specificity and Cross-Reactivity: Compounds were "spiked into drug free pooled oral fluid." This is also a retrospective, laboratory-controlled study. Sample sizes are not explicitly stated for individual compounds but implied multiple tests per compound.

    • Interference (Structurally Unrelated, Endogenous, Exogenous, pH): Potential interferents were "spiked into drug free oral fluid containing oxycodone at ±25% of the cutoff." Orally used products were tested by collecting oral fluid "from volunteers after use of the substances." This combines prospective (volunteers) and retrospective (spiking in lab) approaches. Sample sizes for interferent tests are not explicitly stated for each compound but involve multiple tests per condition.

    • Linearity/Recovery: "Additional pools were made by serially diluting the high concentration specimen with drug free oral fluid... Each pool was collected by Quantisal and Quantisal II oral fluid collection devices and tested in triplicate." This is a retrospective, laboratory-controlled study.

    • Oxycodone Stability in Oral Fluid: "Drug free negative oral fluid spiked with oxycodone... were collected and stored... tested by LC-MS/MS at each time point." This is a retrospective, laboratory-controlled study.

    • Calibration Duration: "Drug free negative oral fluid spiked with oxycodone at ±25% of the cutoff were tested... at time points up to 14 days and in semi-quantitative at time points up to 25 days." This is a retrospective, laboratory-controlled study.

    • Method Comparison: "Eighty (80) deidentified, unaltered clinical oral fluid samples collected by Quantisal II Oral Fluid Collection Devices were obtained from clinical research facilities." This is a retrospective study using real-world clinical samples. Data Provenance: "clinical research facilities" is general, so specific country of origin is not noted.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • The document does not mention any human experts establishing ground truth for the test set in the traditional sense of a diagnostic interpretation study.
    • The ground truth for the "Method Comparison" study was established by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), which is an analytical gold standard, not human expert consensus.
    • For the "Precision," "Specificity," "Interference," "Linearity/Recovery," "Oxycodone Stability," and "Calibration Duration" studies, the "ground truth" was established by the precise spiking concentrations of oxycodone and other compounds into known drug-free oral fluid, and confirmation by mass spectrometry (LC-MS/MS) where mentioned (e.g., for precision studies).

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • No adjudication method involving human experts is described, as the studies primarily rely on analytical measurements and comparisons to a gold standard (LC-MS/MS or known spiked concentrations).

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No MRMC comparative effectiveness study was done. This device is an automated in vitro diagnostic assay for detecting a substance, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    • Yes, this entire submission describes the performance of a standalone algorithm/device (the SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay) without human-in-the-loop performance influencing the assay results themselves. The assay is intended for use with "clinical analyzers." Human involvement is in collecting samples, running the assay, and interpreting the final quantitative or qualitative output, but not in the diagnostic decision-making of the assay itself during the performance evaluation.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The primary type of ground truth used is analytical gold standard, specifically Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), which is considered the definitive method for drug identification and quantification in forensic and clinical toxicology.
    • For spiked samples (in precision, specificity, interference, linearity, stability, and calibration studies), the ground truth was the known, precisely prepared concentration of the analyte.

    8. The sample size for the training set:

    • The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is a homogeneous enzyme immunoassay, which is a biochemical reaction-based test, not a software algorithm that undergoes traditional machine learning training. Therefore, this question is not directly applicable. The data presented are performance characterization studies.

    9. How the ground truth for the training set was established:

    • Since there is no "training set" described for a machine learning model, this question is not applicable. The assay's "learning" or development process would involve optimizing reagent formulations and reaction conditions, not training on labeled data in the AI sense.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1