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510(k) Data Aggregation

    K Number
    K102568
    Device Name
    URIC ACID MODEL 3P39
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    2011-05-06

    (241 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARCHITECT Uric Acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
    Device Description
    The Uric Acid assay is an in vitro diagnostic assay for use on the ARCHITECT c8000 System for the quantitative determination of uric acid in human serum, plasma, or urine using a uricase methodology. The Uric Acid assay is a two-part reaction. Uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide (H2O2). The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-sulfopropyl)-3-methoxy-5methylanaline (HMMPS) in the presence of peroxidase (POD) to yield a quinoneimine dye. The resulting change in absorbance at 604 nm is proportional to the uric acid concentration in the sample. The two-part (R1/R2) configuration of this assay allows reduction of interference from ascorbic acid by inclusion of ascorbic oxidase in the R1 portion of the assay.
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    K Number
    K062862
    Device Name
    OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    2007-04-06

    (193 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers Measurements of Uric Acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
    Device Description
    Not Found
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    K Number
    K040467
    Device Name
    VITALAB URIC ACID REAGENT
    Manufacturer
    CLINICAL DATA, INC.
    Date Cleared
    2004-03-08

    (13 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
    Device Description
    The Vitalab Uric Acid Reagent is a two-part for use with the Vitalab Selectra Analyzer. This reagent determines uric acid through enzymatic oxidation by uricase linked to a Trinder indicator reaction utilizing N-ethyl-N-(bydroxy-3sulfopropyl)-toluidine (TOOS) and 4-aminoantipyrine.
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    K Number
    K031044
    Device Name
    ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
    Manufacturer
    CLINICAL DATA, INC.
    Date Cleared
    2003-07-15

    (105 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
    Device Description
    The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.
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    K Number
    K022096
    Device Name
    URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2003-03-18

    (264 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.
    Device Description
    Not Found
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    K Number
    K023550
    Device Name
    WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
    Manufacturer
    WIENER LABORATORIES S.A.I.C.
    Date Cleared
    2002-12-09

    (48 days)

    Product Code
    KNK
    Regulation Number
    862.1775
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    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wiener lab. Uricostat enzimático AA Líquida. test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid, are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment with cytotoxic drugs.
    Device Description
    End point method. The principle is based on the following reaction system: UOD Uric Acid + 2 H2O + O2- -> Allantoin + H2O2 + CO2 POD 2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------ The amount of uric acid is determined by measuring the absorbance of this pigment. UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone; 3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.
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    K Number
    K012038
    Device Name
    JAS URIC ACID LIQUID REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2001-08-21

    (53 days)

    Product Code
    KNK, JHB
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers. Uric Acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
    Device Description
    Not Found
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    K Number
    K010421
    Device Name
    WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
    Manufacturer
    WIENER LABORATORIES S.A.I.C.
    Date Cleared
    2001-04-13

    (60 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993469
    Device Name
    WAKO L-TYPE UA F TEST
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    1999-11-09

    (27 days)

    Product Code
    KNK, JHB
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for measure uric acid in serum, plasma and are used in the obtain and urine. Measurements and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
    Device Description
    The Wako L-Type UA F Test is an in vivo assay for the quantitative determination of uric acid in serum and plasma. The Wako L-Type UA F is a method utilizing uricase, N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS) and 4-aminoantipyrine.
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    K Number
    K991247
    Device Name
    URIC ACID, MODEL UA112-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (43 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    KNK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uric Acid reagent, product No. UA112-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of Uric Acis in serum, or plasma.
    Device Description
    Not Found
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