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510(k) Data Aggregation

    K Number
    K982277
    Device Name
    MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    1998-07-22

    (23 days)

    Product Code
    CHL,GKF,GKR,JIX,JJS
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stat profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, PCO2, PO2, oxygen saturation (SO2%), hematocrit (Hct), and Hemoglobin (Hb) in heparinized whole blood and pCO2 and PO2 in expired (exhaled) gases.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a blood gas analyzer. It does not contain the kind of detailed information requested about acceptance criteria and a study proving a device meets those criteria. The letter primarily states that the device is substantially equivalent to previously marketed devices and can therefore be marketed.

    Therefore, I cannot extract the requested information from the provided text. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication methods.
    5. MRMC comparative effectiveness study details.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How training set ground truth was established.
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