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510(k) Data Aggregation

    K Number
    K150654
    Device Name
    Cholesterol
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2015-09-29

    (200 days)

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

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.
    Device Description
    The Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8310 R1. Reagent 4 x 20 ml REAGENT COMPOSITION Contents: R1. Reagent 4-Aminoantipyrine, Phenol, Peroxidase (E.C.1.11.1.7, Horse Radish, +25°C), Cholesterol esterase (E.C.3.1.1.13. Pseudomonas, +37°C), Cholesterol oxidase (E.C.1.1.3.6. Nocardia, +37°C), Sodium Azide Concentrations in the Test: 0.25 mmol/l, 6.00 mmol/l, >=0.50 U/ml, >= 0.20 U/ml, >=0.10 U/ml, 0.09% MATERIALS REQUIRED BUT NOT PROVIDED: Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # k942458, Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # k053153, RX series Saline (Cat. No. SA 8396)
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    K Number
    K131554
    Device Name
    RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2014-01-09

    (224 days)

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

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RX Daytona Plus Chemistry analyzer is a bench top fully automated random access clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Daytona Plus includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urine. The RX Daytona Plus is not for Point-Of-Care testing. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements 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. The RX Daytona Plus AST reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
    Device Description
    The RX Daytona Plus is a bench-top fully automated random access clinical analyser intended for use in clinical laboratories. The RX Daytona Plus contains an ISE .module for the measurement of Potassium, Chloride and Sodium. The RX Daytona Plus has the capacity to perform up to 270 photometric tests or 450 tests per hour with ISE's and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment. - Cuvette wash system . - STAT facility . - Direct interface with host computer . - . Automatic re-run and pre-dilution functions The RX Daytona Plus uses dedicated software for easy access to all system facilities and functions. operating functions and provides a comprehensive data management system. Reagents: AST reagent is supplied in a kit containing: - . 4 x 20.0 mL Buffer/ enzyme - . 4 x 7.0 mL α-οχοςlutarate/Coenzyme. The primary reagent contains L-Aspartic acid, MDH, Tris Buffer and preservative, The secondary reagent contains a-oxoglutarate, NADH and preservatives. ISE Electrodes, Sodium, Potassium and Chloride are comprised of ISE Calibrator H and L, ISE diluent, ISE reference solution and ISE etching solution.
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    K Number
    K123977
    Device Name
    RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2013-11-21

    (330 days)

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

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Randox Liquid CK-MB: The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola. Randox CK-MB Calibrator: The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods. The Randox Liquid CK-MB test system for the RX Imola is a prescription use device intended to be used in clinical laboratories only.
    Device Description
    Liquid CK-MB is supplied in a kit containing: - 4 x 20.0 mL CK-MB Buffer - 4 x 6.0 mL CK-MB Substrate. The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.
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    K Number
    K132156
    Device Name
    RANDOX CSF CONTROLS LEVELS 2 AND 3
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2013-10-23

    (104 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox CSF Controls Levels 2 and Level 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for Clinical Chemistry systems. This device is intended for prescription use only.
    Device Description
    The Randox CSF controls consist of a buffered aqueous solution with biological materials; they are supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the following analytes at both levels: Chloride, Glucose, IgG, Lactic Acid, Sodium, Total Protein (Pyrogallol Red), and % Total Protein quoted for Electrophoresis regions at both levels: Albumin, Alpha-1-Globulin, Alpha-2-Globulin, Beta Globulin and Gamma Globulin.
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    K Number
    K132090
    Device Name
    BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2013-08-08

    (27 days)

    Product Code
    DLJ, LAS
    Regulation Number
    862.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Randox Benzodiazepine Calibrator Set: The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only. Randox Benzodiazepine Controls Level 1 & 2: The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.
    Device Description
    The Benzodiazepine Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam. The Calibrators are spiked at 4 different levels which assess below, at and above the cutoff of 200 ng/ml. The Benzodiazepine Controls are manufactured at two levels, one below the cutoff and one above the cutoff of 200 ng/ml. The base matrix used for the manufacture of Randox Benzodiazepine Calibrators and Controls is Drug Free Human Urine. The Benzodiazepine Calibrators and Controls contain the specific drug Oxazepam. The Oxazepam is supplied by Cerilliant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights. Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only. They should not be pipetted by mouth and the normal precautions for handling laboratory reagents should be applied. Randox Benzodiazepine Calibrators and Controls contain sodium azide at 0.05%.
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    K Number
    K131999
    Device Name
    HBA1C CONTROL, LEVEL 1 AND LEVEL 2
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2013-07-26

    (28 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HbAlc Controls Level 1 and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbAlc on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.
    Device Description
    HbA1c Controls are manufactured at two levels, Level 1 and Level 2. Each control is prepared from haemolysed human blood with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 2x0.5ml vials and require reconstitution with 0.5ml of distilled water.
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    K Number
    K131776
    Device Name
    ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2013-07-18

    (31 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert. This device is for prescription use only.
    Device Description
    Randox Aldolase Control is manufactured at two levels, Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilized form in 3x1 mL vials and require reconstitution with 1 mL of distilled water.
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    K Number
    K121603
    Device Name
    RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2012-11-20

    (228 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin, Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This device is for prescription use only.
    Device Description
    Randox Immunoassay Speciality Control (II) is manufactured at three levels, Level 1, Level 2 and Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x1ml vials and require reconstitution with 1ml of distilled water. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
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    K Number
    K113720
    Device Name
    RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2012-09-20

    (276 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total ß-Human Chorionic Gonadotrophin methods on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.
    Device Description
    Randox Maternal Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
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    K Number
    K121746
    Device Name
    RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2012-07-11

    (27 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Microalbumin Liquid Controls are designed for use as assayed quality control materials for the quantitative determination of albumin in human urine. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
    Device Description
    Randox Microalbumin Controls are manufactured at two levels, Level 1 and Level 2. They are single analyte controls made with human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
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