LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K152085
    Device Name
    Liquid CO2-2 (LCO2-2)
    Manufacturer
    RANDOX LABORATORIES LTD
    Date Cleared
    2016-02-24

    (212 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k942458,K100289
    Why did this record match?
    Device Name :

    Liquid CO2-2 (LCO2-2)

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

    For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

    This in vitro diagnostic device is intended for Rx Only.

    Device Description

    The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of the LIQUID CO2-2 (LCO2-2) device, which is an in vitro diagnostic for quantitative determination of Carbon Dioxide in serum and plasma.

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance CharacteristicAcceptance CriteriaReported Device Performance
    Precision(Not explicitly stated as a single numerical criterion, but evaluated consistent with CLSI EP5-A2 guidelines)QC Level 3: SD 0.79, CV 4.5%
    QC Level 2: SD 0.63, CV 5.5%
    SP Level 1: SD 0.75, CV 6.7%
    SP Level 2: SD 0.93, CV 5.0%
    SP Level 3: SD 1.33, CV 3.8%
    Linearity/Reportable RangeDeviation from linearity
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1