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510(k) Data Aggregation

    K Number
    K993984
    Device Name
    SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
    Manufacturer
    SYVA CO.
    Date Cleared
    2000-01-18

    (55 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    K063164
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Emit® II Plus Cannabinoid Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cannabinoids in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

    Device Description

    Not Found

    AI/ML Overview

    The Syva Emit® II Plus Cannabinoid Assay is a homogeneous enzyme immunoassay intended for qualitative and semiquantitative analyses of cannabinoids in human urine, with three different cutoff protocols: 20 ng/mL, 50 ng/mL, and 100 ng/mL. The studies provided demonstrate the device's performance against established predicate methods.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document presents performance data for three protocols (20 ng/mL, 50 ng/mL, and 100 ng/mL). The acceptance criteria are implicitly defined by the reported performance relative to the predicate devices and the internal precision and sensitivity targets.

    Protocol: 20 ng/mL

    Performance CharacteristicAcceptance Criteria (Implicit)Reported Device Performance
    Comparative AnalysisHigh correlation and agreement with predicate method100% agreement with Emit® II Cannabinoid 20 ng Assay (predicate method) in finding samples negative and positive.
    Spiked Sample RecoveryCorrect identification of spiked specimens around cutoff.Correctly identified spiked specimens: = +25% of cutoff as positive.
    Semiquantitative RecoveryRecovery within an acceptable range of nominal concentrations for spiked analytes.79%-106% recovery of nominal concentrations for THC levels 15-55 ng/mL.
    Precision (Qualitative)Acceptable within-run and total precision (%CV).Within-run %CV: 0.5-0.8%; Total %CV: 1.4-2.6%.
    Precision (Semiquantitative)Acceptable within-run and total precision (%CV).Within-run %CV: 1.8-2.3%; Total %CV: 4.9-6.7%.
    SensitivityLowest concentration distinguishable from 0 ng/mL with 95% confidence.= +25% of cutoff as positive.
    Semiquantitative RecoveryRecovery within an acceptable range of nominal concentrations for spiked analytes.86%-118% recovery of nominal concentrations for Cannabinoids levels 25-180 ng/mL.
    Precision (Qualitative)Acceptable within-run and total precision (%CV).Within-run %CV: 0.6-0.7%; Total %CV: 1.4-2.1%.
    Precision (Semiquantitative)Acceptable within-run and total precision (%CV).Within-run %CV: 1.3-1.5%; Total %CV: 2.8-5.4%.
    SensitivityLowest concentration distinguishable from 0 ng/mL with 95% confidence.= +25% of cutoff as positive.
    Semiquantitative RecoveryRecovery within an acceptable range of nominal concentrations for spiked analytes.80%-106% recovery of nominal concentrations for Cannabinoids levels 15-180 ng/mL.
    Precision (Qualitative)Acceptable within-run and total precision (%CV).Within-run %CV: 0.6-0.7%; Total %CV: 1.4-2.0%.
    Precision (Semiquantitative)Acceptable within-run and total precision (%CV).Within-run %CV: 2.1-2.7%; Total %CV: 6.0-7.4%.
    SensitivityLowest concentration distinguishable from 0 ng/mL with 95% confidence.
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