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510(k) Data Aggregation

    K Number
    K130915
    Device Name
    XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2014-05-15

    (408 days)

    Product Code
    JJE, CEM, CFR, CGZ, JGS
    Regulation Number
    862.2160
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use. The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell Carcinoma. The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
    Device Description
    The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples. The instrument includes of the following main parts; - . Sampling Arm (for sample addition to cuvettes) - Reagent Arm (for reagent addition to cuvettes) . - Reaction Station (cuvettes) . - Sample Plate Station (for loading samples) . - Reagent Plate Station (for on board reagents) . - . Photometer (for reaction analysis reading) - Wash Station (for cleaning of reaction cuvettes) . - Electronic Boards (for controlling the open functions) . The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use. The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.
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    K Number
    K080623
    Device Name
    CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2008-11-17

    (257 days)

    Product Code
    CHH, CDT
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only. For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.
    Device Description
    Not Found
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    K Number
    K080618
    Device Name
    DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2008-05-23

    (79 days)

    Product Code
    LCP, CGA
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to be used for the quantitative determination of glucose oxidase in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia and of pancreatic islet cell carcinoma. This reagent set is intended for in vitro diagnostic use only. This product is to be used for the quantitative determination of hemoglobin A 1 c in human blood. The determination of hemoglobin A 1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A 1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A 1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only. This product is to be used for the quantitative determination of fructosamine in human serum. The determination of fructosamine is most commonly performed for the evaluation of glycemic control in diabetes. Fructosamine values provide an indication of glucose levels over the preceding 2-3 weeks. A higher fructosamine value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K022519
    Device Name
    LDL CHOLESTEROL (AUTOMATED)
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-09-30

    (62 days)

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

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers. LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
    Device Description
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    K Number
    K021671
    Device Name
    JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-07-19

    (59 days)

    Product Code
    LBS, JIX, JJY
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers. HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
    Device Description
    Not Found
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    K Number
    K020454
    Device Name
    CHEMISTRY CALIBRATOR
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-04-08

    (56 days)

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

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. "A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens."
    Device Description
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    K Number
    K020282
    Device Name
    JAS AMYLASE LIQUID REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-02-28

    (31 days)

    Product Code
    JFJ
    Regulation Number
    862.1070
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers. Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
    Device Description
    Not Found
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    K Number
    K013912
    Device Name
    CREATINE KINASE (CK-NAC)
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-01-18

    (52 days)

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

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers. Creatine kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
    Device Description
    This Reagent is intended for the in vitro quantitative determination of creatine kinase in human serum.
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    K Number
    K013698
    Device Name
    AST (SGOT)
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2001-12-21

    (44 days)

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

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
    Device Description
    Not Found
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    K Number
    K012332
    Device Name
    JAS CARBON DIOXIDE LIQUID REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2001-09-06

    (45 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAS Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers. Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
    Device Description
    Not Found
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