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    K Number
    K061830
    Device Name
    STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    2006-11-01

    (126 days)

    Product Code
    CIG,JIT,JJY
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+

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

    The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (02Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Gu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.

    The intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin and total bilirubin in human blood using the Stat Profile Critical Care Xpress CO-Oximeter Analyzer.

    Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA to Nova Biomedical Corporation for their Stat Profile Critical Care Xpress (CCX 1+) System. It grants market clearance for the device based on substantial equivalence to existing predicate devices.

    The document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other information requested in your prompt. This type of FDA letter confirms regulatory clearance but does not typically include the technical study results.

    Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would contain the performance data and study details.

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