LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974822
    Device Name
    AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1998-01-22

    (29 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K880447,K911755
    Why did this record match?
    Device Name :

    AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL

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

    AVL OPTI-check assayed control is intended to be used to monitor the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in the AVL OPTI Critical Care Analyzer, as well as other devices measuring the same parameters and ionized calcium and chloride.

    For In Vitro Diagnostic Use

    The determination of acid-base status, and concentration of carbon dioxide, oxygen, electrolytes, total hemoglobin and oxygen saturation is an important adjunct to patient monitoring for a variety of clinical conditions described in the labeling for those devices used for these purposes. Since therapeutic regimes are often determined by the results obtained in patient samples, the instruments used for these analyses must meet stringent requirements for accuracy and precision of measurement. It should be the goal of the quality control program in institutions performing these analyses to determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained.

    Device Description

    OPTI-check is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the OPTI. It contains a stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the AVL OPTI Critical Care Analyzer. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. OPT-check provides a convenient method of performing daily QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.

    While the product is optimized for performance on the AVL OPTI Critical Care Analyzer, it may be used to monitor the measurement of blood gas and electrolyte values in conventional instrumentation. OPTI-check contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, and suitable concentrations of microbeads to simulate clinically relevant values of tHb and oxygen saturation.

    AI/ML Overview

    The provided document describes the AVL OPTI-check Control, a multi-analyte control solution. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:

    1. Table of Acceptance Criteria and Reported Device Performance:

    AnalyteAcceptance Criteria (implied from study conclusion)Reported Device Performance (implied from study conclusion)
    pH, PCO2, PO2, Na, K, ctHb, SO2, ionized calcium, chlorideWithin manufacturer's stated claims for imprecisionWithin manufacturer's stated claims for imprecision
    pH, PCO2, PO2, Na, K, ctHb, SO2No significant difference (P
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1