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510(k) Data Aggregation

    K Number
    K203771
    Device Name
    Urea Nitrogen2
    Manufacturer
    Abbott Ireland Diagnostics Division
    Date Cleared
    2022-05-31

    (524 days)

    Product Code
    CDQ, CDO
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urea Nitrogen2 assay is used for the quantitation of Urea Nitrogen in human serum, plasma, or urine on the ARCHITECT c System. The Urea Nitrogen2 assay is to used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
    The Urea Nitrogen2 assay is an automated clinical chemistry assay. The Urea Nitrogen2 assay is a modification of a totally enzymatic procedure. The test is performed as a kinetic assay in which the initial rate of the reaction is linear for a limited period of time. Urea in the sample is hydrolyzed by urease to ammonia and carbon dioxide. The second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.
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    K Number
    K140690
    Device Name
    BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Date Cleared
    2014-09-02

    (167 days)

    Product Code
    CDQ, CEM, CGZ, JGS, JJE
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BS-480/BS-490/CLC7201 chemistry analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney functions and other diseases associated with protein catabolism.
    Device Description
    The BS-480/BS-490/CLC72i Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The UREA was cleared under K971309 and is the chosen assay to demonstrate performance for the photometric unit. The BS-480 Chemistry Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.
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    K Number
    K110675
    Device Name
    EASYRA UREA NITROGEN AND CREATININE REAGENTS
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2011-04-21

    (42 days)

    Product Code
    CDQ, CGX
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasyRA BUN Reagent: The EasyRA Urea Nitrogen (BUN) Reagent is for the measurement of urea nitrogen in serum and plasma using the "EasyRA chemistry analyzer". Urea measurements are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only. EasyRA CREA Reagent: The EasyRA Creatinine (CREA) Reagent is for the measurement of Creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K073295
    Device Name
    UREA/BUN, SCAL, NORTROL, ABTROL
    Manufacturer
    THERMO FISHER SCIENTIFIC OY
    Date Cleared
    2008-05-29

    (188 days)

    Product Code
    CDQ, JIX, JJY
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy. For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy. For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
    Device Description
    The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet.
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    K Number
    K070146
    Device Name
    ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
    Manufacturer
    HORIBA ABX
    Date Cleared
    2007-10-12

    (269 days)

    Product Code
    CDQ, JJY, URI
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
    Device Description
    All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
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    K Number
    K060120
    Device Name
    TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2006-03-27

    (69 days)

    Product Code
    CDQ, CGA, CGX, CIC
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma. This reagent set is intended for in vitro diagnostic use only.
    Device Description
    The Teco CX3 Reagent Set for SYSNCHRON CX designed for use on the Beckman CX System. The Reagent Set includes BUN, Calcium, Creatinine and Glucose.
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    K Number
    K041051
    Device Name
    RAICHEM BUN RATE REAGENT (LIQUID)
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2004-06-30

    (72 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reaqent is for the quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma by measurement of the initial rate of reaction. This urea nitrogen test system is a device intended to measure urea nitrogen (an endproduct of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
    Urea Nitrogen (BUN) test system
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    K Number
    K024182
    Device Name
    PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
    Manufacturer
    PRECISION SYSTEMS, INC.
    Date Cleared
    2003-03-03

    (74 days)

    Product Code
    CDQ, CEO, CGA, CGS, CGX, CHH, CHJ, CIG, CIT, CIX, CJE, CJY, JGJ, JGY, JJF, KNK
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.
    Device Description
    The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.
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    K Number
    K021385
    Device Name
    ATAC PAK BUN REAGENT
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2002-07-12

    (71 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC PAK BUN Reagent Kit is intended for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
    The ATAC PAK BUN Reagent determines urea nitrogen through the enzymatic action of urease and glutamate delydrogenase. The resulting decrease in absorbance at 340 nm is proportional to the urea nitrogen concentration of the sample.
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    K Number
    K012649
    Device Name
    RAICHEM BUN RATE REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2001-10-15

    (63 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    CDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is for the quantitative in vitro enzymatic determination of urea nitrogen (BUN) in serum or plasma. For in vitro diagnostic use only.
    Device Description
    Not Found
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