LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972868
    Device Name
    TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
    Manufacturer
    BIONOSTICS, INC.
    Date Cleared
    1997-08-28

    (24 days)

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

    TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL

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

    This material is intended for use to monitor the measurements of: a. pH and pCO2 and pO2 in blood gas analyzers, - b. Na, K, Cl, Li, Ca++, and Mg++ in electrolyte analyzers, and; - c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites. The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte. This product is for In Vitro Diagnostic Use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Bionostics, Inc. regarding their "Blood Gas/Electrolyte/Glucose, Lactate, BUN, and Creatinine Control" product.

    This document

    • determines substantial equivalence for a specific in-vitro diagnostic control product.
    • does not contain any information about a study, acceptance criteria, or device performance data.
    • does not describe any AI/ML components.
    • does not mention any details about sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot extract the requested information to fill in the table and answer the questions. The text is purely a regulatory communication.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1