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510(k) Data Aggregation

    K Number
    K131051
    Device Name
    HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
    Manufacturer
    HITACHI CHEMICAL DIAGNOSTICS, INC.
    Date Cleared
    2013-06-07

    (53 days)

    Product Code
    JGQ, CIX
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    JGQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
    Device Description
    The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters. calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridges TP and ALB. Chemistry reactions: (TP) Proteins in samples react with the biuret reagent to form a purplered complex. The concentration of total protein can be determined by measuring the absorbance of the purple-red substance. (ALB) Albumin in the sample combines with bromcresol green to form a blue-green dye conjugate. The albumin concentration is directly proportional to the color intensity and can be determined photometrically by measuring the absorbance of this resulting blue-green color.
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    K Number
    K072638
    Device Name
    ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2007-10-19

    (31 days)

    Product Code
    JGQ
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    JGQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as metabolic or nutritional disorders. Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria. CSF protein measurements are used in diagnosis and treatment of conditions such as meningitis, brain tumors and infections of the central nervous systems.
    Device Description
    The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect.
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    K Number
    K071239
    Device Name
    TOTAL PROTEIN URINE/CSF GEN.3
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2007-09-14

    (134 days)

    Product Code
    JGQ, JIX
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    JGQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid on the COABS INTEGRA systems. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidnev or bone marrow as well as metabolic or nutritional disorders. Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria. CSF protein measurements are used in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems. C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems.
    Device Description
    The COBAS INTEGRA Total Protein Urine/SCG Gen. 3 reagent is intended for use on the COBAS INTEGRA systems for the quantitative determination of protein in urine and cerebrospinal fluid.
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    K Number
    K981295
    Device Name
    UPRO
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-10-01

    (175 days)

    Product Code
    JGQ
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    JGQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the ALCYON™ Analyzer. Identification of urinary protein is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria. CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous system.
    Device Description
    Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the ALCYON™ Analyzer. The Urine/CSF Protein assay is a clinical chemistry assay using a turbidimetric procedure in which benzethonium chloride is used as the protein denaturing agent. Proteins present in the urine or CSF are denatured by benzethonium chloride resulting in the formation of a fine suspension which is quantitated turbidimetrically at 405 mm. The reagent has been modified to overcome the problem of high concentration (Hook) effect, where very high concentrations of protein in urine can cause an apparent zero or low reading.
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    K Number
    K981682
    Device Name
    UPRO
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-09-21

    (131 days)

    Product Code
    JGQ
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    JGQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urine/CSF Protein assay is used for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF) on the AEROSET System. Identification of urinary protein is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
    Device Description
    Urine/CSF Protein is an in vitro diagnostic assay for the quantitative determination of protein in human urine or cerebrospinal fluid (CSF). The Urine/CSF Protein assay is a clinical chemistry assay using a turbidimetric procedure in which benzethonium chloride is used as the protein denaturing agent. Proteins present in the urine or CSF are denatured by benzethonium chloride resulting in the formation of a fine suspension which is quantitated turbidimetrically at 405 nm. The reagent has been modified to overcome the problem of high concentration (Hook) effect, where very high concentrations of protein in urine can cause an apparent zero or low reading.
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