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510(k) Data Aggregation

    K Number
    K972733
    Device Name
    AVL OMNI ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1997-09-09

    (50 days)

    Product Code
    CGA,CGZ,CHL,GHS,GLY,JFP,JGS
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K954612,K960120,K946206,K955793
    Why did this record match?
    Device Name :

    AVL OMNI 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 and lactate 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.

    The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, HHb, O2Hb, COHb, MetHb, SulfHb, Nat, K+, CI, ionized Ca*, Hematocrit, glucose and lactate in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.

    Device Description

    The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 16 tests per sample.

    AI/ML Overview

    The provided text describes the AVL OMNI™ Combi Analyzer and its intended use, but it does not contain a specific section detailing the acceptance criteria and a study proving the device meets those criteria in a structured table or comprehensive study report. The document describes non-clinical tests for precision and linearity for Glucose and Lactate as additions to previous submissions, and clinical tests to demonstrate correlation with legally marketed predicate devices.

    However, based on the provided text, I can infer details regarding the "Precision" and "Linearity" tests for the added Glucose and Lactate analytes, which are key performance indicators for this type of device.

    Here's an attempt to construct the requested information, acknowledging the limitations of the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state numerical "acceptance criteria" for precision or linearity. Instead, it describes how precision and linearity were determined and then concludes that there was "no significant difference in mean values (P

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