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510(k) Data Aggregation

    K Number
    K030003
    Device Name
    ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-09-29

    (270 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of conjugated bilirubin in serum and plasma. Conjugated bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. 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 Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is substantially equivalent to the Trace Direct Bilirubin Reagent, product UG38 (Trace Scientific, Ltd. of Melbourne, Australia) calibrated with the Sigma Bilirubin Calibrator, Total and Direct, product no. B8652 (Sigma Diagnostics, Inc. St. Louis, MO). The effectiveness of ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown in the following studies. The ATAC Direct Bilirubin Reagent determines conjugated bilirubin through its reaction with diazotized sulfanilic acid to form a red-purple complex. The resulting increase in absorbance at 546 nm is proportional to the direct bilirubin concentration in the sample.
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    K Number
    K030014
    Device Name
    ATAC TOTAL BILIRUBIN REAGENT
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-09-26

    (267 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Total Bilirubin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block. 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 Total Bilirubin Reagent determines total bilirubin through its reaction with diazotized sulfanilic acid in the presence of dimethylsulfoxide to form a red-purplex. The resulting increase in absorbance at 546 nm is proportional to the total bilirubin concentration in the sample.
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    K Number
    K030621
    Device Name
    ATAC CALIBRATOR
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-03-19

    (20 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Calibrator Kit is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total bilirubin, total protein and urea in human specimens. 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 Calibrator Kit is intended to calibrate the ATAC Clinical Systems for the quantitative determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total protein and urea nitrogen.
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    K Number
    K023105
    Device Name
    ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-03-13

    (176 days)

    Product Code
    CIC
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).
    Device Description
    The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.
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    K Number
    K030010
    Device Name
    ATAC PAK MAGNESIUM REAGENT
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-03-10

    (67 days)

    Product Code
    JGJ
    Regulation Number
    862.1495
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
    Device Description
    The ATAC PAK Magnesium Reagent determines magnesium through its selective binding by xylidyl blue to form a red-purple chelate. The resulting increase in absorbance at 510 nm is proportional to the magnesium concentration in the sample.
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    K Number
    K030006
    Device Name
    ATAC PAK ALBUMIN REAGENT
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-03-07

    (64 days)

    Product Code
    CIX
    Regulation Number
    862.1035
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC PAK Albumin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
    Device Description
    The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The ATAC PAK Albumin Reagent determines albumin by the selective binding of bromcresol green. The resulting increase in absorbance at 630 nm is proportional to the albumin concentration in the sample.
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    K Number
    K030015
    Device Name
    ATAC PAK PHOSPHORUS REAGENT
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-03-07

    (64 days)

    Product Code
    CEO
    Regulation Number
    862.1580
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
    Device Description
    The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.
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    K Number
    K023407
    Device Name
    ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-02-14

    (127 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Creatinine 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 creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.
    Device Description
    The ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The ATAC PAK Creatinines creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample.
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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?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    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
    K020575
    Device Name
    ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2002-04-12

    (50 days)

    Product Code
    MRR, JIT
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELAN DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
    Device Description
    The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which specifically consumes non-LDL cholesterol in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDL-cholesterol, allowing it to react with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.
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