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510(k) Data Aggregation

    K Number
    K041427
    Device Name
    THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
    Manufacturer
    ARKRAY, INC.
    Date Cleared
    2004-11-24

    (180 days)

    Product Code
    CGA,CIS,LCP
    Regulation Number
    862.1345
    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 SpotChem EZ Glucose test system is an in vitro diagnostic procedure intended to measure Glucose in whole blood, serum, or plasma on the SpotChem EZ analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic isle cell carcinoma.

    The SpotChem EZ Fructosamine test system is an in vitro diagnostic procedure intended to measure Fructosamine in serum or plasma on the SpotChem EZ analyzer. Fructosamine measurements are used to assess the level of control of a patient's diabetes and to adjust the proper insulin dose to a patient. Elevated levels of fructosamine indicate uncontrolled diabetes in a patient.

    The SpotChem EZ AST test system is an in vitro diagnostic procedure intended to measure AST in serum or plasma on the SpotChem EZ analyzer. AST measurements are used in the diagnosis and treatment of certain liver and heart diseases.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification for three in vitro diagnostic devices from ARKRAY, Inc.: The SpotChem EZ Glucose Test, The SpotChem EZ Fructosamine Test, and The SpotChem EZ AST Test.

    Based on the provided text, the document focuses on the indications for use and regulatory classification of these devices, establishing their substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific device performance data from a study, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

    Therefore, I cannot directly answer your request for acceptance criteria and study details using only the provided text. The document is a regulatory approval letter and indications for use statements, not a detailed technical report or study summary.

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