LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011878
    Device Name
    EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
    Manufacturer
    SYVA CO.
    Date Cleared
    2001-08-13

    (59 days)

    Product Code
    DKJ,DLJ
    Regulation Number
    862.3830
    Type
    Traditional
    Panel
    Toxicology (TX)
    Reference & Predicate Devices
    K951290
    Why did this record match?
    Reference Devices :

    K951290

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

    The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.

    Device Description

    The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma.

    AI/ML Overview

    The Emit® tox™ Salicylic Acid Assay is intended for the quantitative analysis of salicylic acid in human serum or plasma to diagnose and treat salicylic acid overdose or monitor therapeutic levels.

    Here's a breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Implied)Reported Device Performance
    SpecificityNo interference from tested compounds at specified levels.Compounds with potential cross-reactivity did not interfere.
    Comparative AnalysisStrong correlation to predicate device. (>0.993, slope 0.941)Correlation of 0.993 with a slope of 0.941 to predicate (Abbott AxSYM® Salicylate Assay).
    Precision (Within-Run)Acceptable coefficient of variation (%CV). (5 mg/dL)Sensitivity level is ≤5 mg/dL Salicylic Acid.
    Endogenous InterferenceAverage recovery close to 100% compared to control samples. (>98.7% 104% 98.6%
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1