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510(k) Data Aggregation

    K Number
    K980883
    Device Name
    N-ASSAY GLU-UL
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1998-09-03

    (178 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the N-ASSAY Glu-UL Reagent is for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. For in vitro diagnostic use only.
    Device Description
    The N-ASSAY Glu-UL reagent is based on an enzymatic hexokinase/glucose-6phosphate dehydrogenase method, shows good correlation with similar glucose reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is a convenient ready-to-use liquid type reagent. In this method, serum D-glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-Phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The increase in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of the NADPH, is directly proportional to the glucose concentration in the sample.
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    K Number
    K981276
    Device Name
    N-ASSAY L D-BIL
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1998-05-01

    (23 days)

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

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the N-ASSAY L D-BIL Reagent is for the quantitative measurement of direct bilirubin in human serum in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.
    Device Description
    The N-ASSAY L D-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar direct bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. In this method, a serum sample containing direct bilirubin is mixed with the reagent containing sodium nitrite. Direct billrubin is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.
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    K Number
    K981289
    Device Name
    N-ASSAY L T-BIL
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1998-04-27

    (19 days)

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

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the N-ASSAY L T-BIL Reagent is for the quantitative determination of serum Total Bilirubin in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.
    Device Description
    The N-ASSAY L T-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar Total Bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. In this method, a serum sample containing total bilirubin is mixed with the reagent containing sodium nitrite. Total bilirubin (direct bilirubin) is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the total billinubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.
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    K Number
    K980900
    Device Name
    N-ASSAY CPK-L
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1998-03-26

    (16 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the N-ASSAY CPK-L Reagent is for the quantitative determination of serum creatine phosphokinase (CPK) activity in human serum in the diagnosis and treatment of myocardial infarction and muscle diseases such as muscular dystrophy.
    Device Description
    The N-ASSAY CPK-L reagent is based on an optimized CPK kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar CPK reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. The N-ASSAY CPK-L reagent utilizes an enzymatic method. In this procedure, creatine phosphate is dephosphorylated by creatine phosphokinase (CPK) in the presence of adenosine disphosphate (ADP) to produce creatine and adenosine triphosphate (ATP). ATP is dephosphorylated by hexokinase in the presence of D-glucose to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate. Glucose-6-phosphate dehydrogenase specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 (sub) and can be detected spectrophotometrically. The increase per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of NADPH, is directly proportional to CPK activity in the sample.
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    K Number
    K980902
    Device Name
    N-ASSAY L AST/GOT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1998-03-26

    (16 days)

    Product Code
    CIT
    Regulation Number
    862.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases. For in vitro diagnostic use only.
    Device Description
    The N-ASSAY L AST/GOT reagent is based on an the optimized enzymatic AST kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar AST reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. In this procedure, L-Aspartic Acid and a-Ketoglutaric Acid are translated by aspartate aminotransferase (AST) to produce Oxalacetic Acid and Glutamic Acid. Oxalacetic Acid is reduced by Malic Dehydrogenase to produce Malic Acid with the concurrent oxidation of nicotinamide adenine dinucleotide reduced (NADH) to nicotinamide adenine dinucleotide (NAD). The NADH absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The decrease per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the decrease of NADH, is directly proportional to the AST activity in the sample.
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    K Number
    K971985
    Device Name
    N-ASSAY TIA PLASMINOGEN TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-10-20

    (144 days)

    Product Code
    GGP, DDX
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-turbidimetric assay. Decreased levels of plasminogen are of clinical importance. Low levels of plasminogen are usually due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.
    Device Description
    N-Assay TIA Plasminogen Test Kit
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    K Number
    K972257
    Device Name
    N-ASSAY TIA ANTITHROMBIN III TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-10-20

    (125 days)

    Product Code
    DDQ, JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-TII is also helpful in monitoring heparin therapy.
    Device Description
    Not Found
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    K Number
    K964292
    Device Name
    N-ASSAY TIA APO A1 TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow. of apoprotein A-l is useful in the diagnosis of atherosclerosis.
    Device Description
    Not Found
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    K Number
    K964294
    Device Name
    N-ASSAY TIA APO A1/B MULTI CALIBRATOR
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits. which are immuno turbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.
    Device Description
    Not Found
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    K Number
    K964296
    Device Name
    N-ASSAY TIA APO B TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CRESTAT DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.
    Device Description
    Not Found
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