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510(k) Data Aggregation

    K Number
    K040579
    Device Name
    CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
    Manufacturer
    CHOLESTECH CORP.
    Date Cleared
    2004-06-18

    (106 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOLESTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of CRP in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
    Device Description
    The Cholestech LDX System combines immunoassay and solid-phase technology to measure CRP. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX hs-CRP cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The resultant color in the reaction is measured by reflectance photometry. A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading to the CRP concentration in mg/L.
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    K Number
    K032027
    Device Name
    CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
    Manufacturer
    CHOLESTECH CORP.
    Date Cleared
    2003-09-05

    (66 days)

    Product Code
    CIS
    Regulation Number
    862.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOLESTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cholestech LDX aspartate aminotransferase (AST) test is for the in vitro quantitative determination of AST in whole blood or serum on the Cholestech LDX Analyzer. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis), and heart diseases.
    Device Description
    The Cholestech LDX System combines enzymatic methodology and solid-phase technology to measure AST. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX AST cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the AST reaction pad. The Cholestech LDX Analyzer measures Aspartate aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. 12- Aspartic acid aminotransferase catalyzes the transfer of amino groups from L-Aspartic acid to alpha-Ketoglutarate producing oxaloacetate and glutamate. Oxaloacetate Decarboxylase converts the Oxaloacetate to Pyruvate by the removal of CO2. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the AST concentration of the sample. The resultant color in the reaction is measured by reflectance photometry. A brown magnetic stripe on each cassette contains the calibration required for the Cholestech LDX Analyzer to convert the reflectance reading to the AST concentration in U/L. 37°C.
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    K Number
    K991834
    Device Name
    CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
    Manufacturer
    CHOLESTECH CORP.
    Date Cleared
    1999-09-09

    (104 days)

    Product Code
    CKD
    Regulation Number
    862.1030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOLESTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cholestech L·D·X Alanine aminotransferase Test (ALT) is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L.D.X Analyzer. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
    Device Description
    The Cholestech L·D·X Alanine Aminotransferase Test (ALT) combines an enzymatic methodology and a solid-phase technology to measure ALT in whole blood or serum. Blood from a fingerstick is collected into a lithium heparin coated capillary tube (venous whole blood serum is also acceptable) and dispensed into a L·D·X cassette. The cassette is then placed into the Cholestech L·D·X where a unique system separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the ALT reaction pad. The Cholestech L•D•X Analyzer measures alanine aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. Alanine aminotransferase catalyzes the transfer of amino groups from L-Alanine and α-Ketoglutarate to pyruvate and glutamate. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the ALT concentration of the sample. The resultant color in the reaction is measured by reflectance photometry. L-Alanine + α -Ketoglutarate Alanine Aminotransferase → Pyruvate + Glutamate Pyruvate + Phosphate + O2 + H2O Pyruvate Oxidase → Acetylphosphate + CO2 + H2O2 Indicator + H2O2 Peroxidase → Colored Blue Dye + H2O A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech L•D•X Analyzer to convert the reflectance reading to the ALT concentration in U/L at 37° C.
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    K Number
    K972012
    Device Name
    CHOLESTECH BUN/CREATININE TEST SYSTEM
    Manufacturer
    CHOLESTECH CORP.
    Date Cleared
    1997-07-24

    (55 days)

    Product Code
    CDN, JFY
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOLESTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of Blood Urea Nitrogen and creatinine in whole blood. Creatinine values are used as indications of renal function. Blood Urea Nitrogen values are valuable in the diagnosis of renal diseases. For professional in vitro diagnostic use only.
    Device Description
    Not Found
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