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510(k) Data Aggregation

    K Number
    K033278
    Device Name
    RANDOX URIC ACID
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2004-02-27

    (140 days)

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

    CDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is nonabsorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is measured using a bichromatic (293, 700nm) end-point technique. 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. This application sheet has been developed for the Dade Dimension Clinical Chemistry Analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.
    Device Description
    The Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is nonabsorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is measured using a bichromatic (293, 700nm) end-point technique.
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    K Number
    K992798
    Device Name
    SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1999-09-28

    (40 days)

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

    CDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum, plasma or urine on both automated and manual systems. The Sigma Diagnostics INFINJTY™ Uric Acid Reagent is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by the 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
    This reagent is based upon the methods of Trivedi and Kabasakalland with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB). The series of reactions involved in the assay system is as follows: - Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1 . Uric Acid + O2 + H2O _ Uricase _ Allantoin + CO2 + H2O2 - The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample. HoOs + 4-AAP + TBHB Peroxidase \ Ouinoneimine + H2O
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    K Number
    K982251
    Device Name
    SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1998-08-18

    (53 days)

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

    CDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum or urine on both automated and manual systems. The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the 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
    This reagent is based upon the methods of Trivedi and Kabasakallan with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB). The series of reactions involved in the assay system is as follows: - Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1. Uric Acid + O2 + H2O Uricase > Allantoin + CO2 + H2O2 - The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample. H2O2 + 4-AAP + TBHB Peroxidase > Quinoneimine + H2O
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    K Number
    K981766
    Device Name
    URIC ACID
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-06-19

    (31 days)

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

    CDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine. 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
    Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to vield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the uric acid concentration in the sample.
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    K Number
    K981189
    Device Name
    URIC ACID
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-05-07

    (35 days)

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

    CDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. 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
    Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 550 nm is proportional to the uric acid concentration in the sample.
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    K Number
    K971485
    Device Name
    URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    Manufacturer
    TRACE AMERICA, INC.
    Date Cleared
    1997-05-27

    (34 days)

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

    CDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of Uric Acid in human serum and urine for clinical diagnosis. "This 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", CFR 862.1775
    Device Description
    TRACE !!!ric Acid - DST Reagent
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    K Number
    K955752
    Device Name
    OLYMPUS URIC ACID REAGENT
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1996-01-31

    (43 days)

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

    CDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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