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510(k) Data Aggregation

    K Number
    K990092
    Device Name
    AVL OMNI MODULAR ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1999-01-29

    (18 days)

    Product Code
    CHL,CDS,CEM,CGA,CGZ,GKF,GKR,GLY,JFP,JGS,KHP
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K960120,K940918,K953239
    Why did this record match?
    Device Name :

    AVL OMNI MODULAR ANALYZER

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

    The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb, SulfHb and metabolites; glucose, lactate and urea nitrogen in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.

    Device Description

    The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 17 tests per sample.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the AVL OMNI™ Modular Analyzer, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state quantitative "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it implicitly defines acceptance through the concept of "substantial equivalence" to predicate devices and the demonstration of "no significant difference in mean values" and "correlation" during clinical trials. The "reported device performance" is largely described qualitatively.

    Parameter/TestAcceptance Criteria (Implicit)Reported Device Performance (Qualitative)
    Substantial EquivalenceThe device should be substantially equivalent in function, safety, and efficacy to specific legally marketed predicate devices.Stated as substantially equivalent to "Combi Analyzers" and specifically for Urea Nitrogen to NOVA Biomedical ULTRA H [K960120] and i-STAT 200 Portable Clinical Analyzer (K940918).
    PrecisionDemonstrated acceptable "Within-Run (S_wr), Between-Day (S_dd) and Total (S_T) precision." (No numerical thresholds provided)."Typical Within-Run (S_wr), Between-Day (S_dd) and Total (S_T) precision were evaluated" for all assays. The conclusion statement implies the precision was found acceptable.
    Linearity in Aqueous SolutionsDemonstrated linearity across a known range of values. (No numerical thresholds provided).Aqueous standard solutions measured on three AVL OMNI™ units demonstrated linearity. The conclusion statement implies the linearity was found acceptable.
    Linearity in SerumDemonstrated linearity by diluting patient-sample pools. (No numerical thresholds provided).Patient-sample pools diluted and measured on two AVL OMNI™ instruments demonstrated linearity. The conclusion statement implies the linearity was found acceptable.
    InterferencesNo significant effects on measurement from various analytes or drugs. (No numerical thresholds provided)."No significant effects on measurement were demonstrated at the concentrations evaluated" for urea nitrogen.
    Clinical CorrelationNo significant difference in mean values (P
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