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    K Number
    K993980
    Device Name
    SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
    Manufacturer
    SYVA CO.
    Date Cleared
    2000-02-01

    (69 days)

    Product Code
    DML
    Regulation Number
    862.3040
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K903153
    Why did this record match?
    Device Name :

    SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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

    The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human serum or plasma.
    The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.

    Device Description

    The Syva Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in quantitative analysis of ethyl alcohol in human urine, serum, or plasma.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Emit® II Plus Ethyl Alcohol Assay, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Study CategoryAcceptance Criteria (Implied)Reported Device Performance
    Comparative AnalysisExcellent correlation (high correlation coefficient, slope near 1) to predicate device.Serum: Correlation of 0.986 with predicate method, slope of 1.000.
    Urine: Correlation of 0.997 with predicate method, slope of 1.000.
    PrecisionAcceptable within-run and total precision (low %CV).Within-run: %CV ranging from 1.39% to 1.55%.
    Total precision: %CV ranging from 1.61% to 1.78%.
    SpecificityAcceptable levels of cross-reactivity (low percentage).Cross-reactivity ranging from
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