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    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
    Why did this record match?
    Device Name :

    SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

    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 (
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