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    K Number
    K963964
    Device Name
    AVL COMPACT 3 PH/BLOOD GAS ANALYZER
    Manufacturer
    AVL SCIENTIFIC CORP.
    Date Cleared
    1996-11-29

    (58 days)

    Product Code
    CHL
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K942616,K895317
    Why did this record match?
    Device Name :

    AVL COMPACT 3 PH/BLOOD GAS ANALYZER

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

    The AVL COMPACT 3 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood.

    Device Description

    The AVL COMPACT 3 pH / Blood Gas Analyzer is a fully automatic, microprocessor-controlled medical instrument that measures pH, PCO2 and PO2. Communication to the device is accomplished simply with the use of a keypad. The analyzer communicates to the user through a 4-line alphanumeric display with 20 characters per line and with a thermal printer using heat sensitive paper to output measured values, calibration reports, electrode voltages and other information.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:

    Device: AVL COMPACT 3 pH/Blood Gas Analyzer

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document primarily focuses on demonstrating that the AVL COMPACT 3 is substantially equivalent to its predecessor (COMPACT 2) and that the changes made (numeric keypad, optimized sample volume requirements) do not introduce significant differences in performance. The acceptance criteria are implicitly derived from the existing performance of the COMPACT 2 and the statistical comparison to the "gold standard" methods (tonometry and AVL OMNI).

    Metric / ParameterAcceptance Criteria (Implicit from Equivalence)Reported Device Performance (AVL COMPACT 3)
    Numeric Keypad FunctionCorrect input/output of values across full range."Operation of the numeric keypad was validated by test of input values from the upper and lower limits in addition to typical input values. The numeric keypad function test was judged passed."
    pH MeasurementNo significant difference (P
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