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    K Number
    K053401
    Device Name
    SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
    Manufacturer
    ARKRAY, INC.
    Date Cleared
    2006-03-24

    (108 days)

    Product Code
    CIC,CEK,CGA,CGX,CIX,JGZ
    Regulation Number
    862.1145
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS

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

    The SPOTCHEM II Chemistry Basic 1 Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcum measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

    The SPOTCHEM II Chemistry Basic 1 Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

    The SPOTCHEM II Chemistry Basic 1 Glucose test is intended to measure the glucose concentration in serum, plasma, and whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

    The SPOTCHEM II Chemistry Basic 1 Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.

    The SPOTCHEM II Chemistry Basic 1 Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

    The SPOTCHEM II Chemistry Basic 2 ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

    The SPOTCHEM II Chemistry Basic 2 Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

    The SPOTCHEM II Chemistry Basic 2 Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidray, or oo ne marrow, as well as other metabolic and nutritional disorders.

    The SPOTCHEM II Chemistry Basic 2 AST test is intended to measure AST activity in serum, plasma, and whole blood. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and head formants

    The SPOTCHEM II Chemistry Basic 2 ALT test is intended to measure ALT activity in serum, plasma, and whole blood. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Arkray SPOTCHEM II Chemistry Basic 1 and Arkray SPOTCHEM II Chemistry Basic 2 devices, outlining their indications for use. It does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

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