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510(k) Data Aggregation

    K Number
    K192842
    Device Name
    HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
    Manufacturer
    Eurotrol B.V.
    Date Cleared
    2019-11-15

    (43 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eurotrol B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.
    Device Description
    HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® Duo contains stroma-free bovine hemolysate with hemoglobin in cyanmethemoglobin (CNMetHb) form and a bioburden-controlling agent. For daily quality control, three physiological relevant levels are available. HemoTrol® Duo solutions are filled in reclosable plastic primary containers. Each bottle contains 1.0 ml of HemoTrol® Duo solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
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    K Number
    K182744
    Device Name
    HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
    Manufacturer
    EUROTROL B.V.
    Date Cleared
    2019-02-01

    (126 days)

    Product Code
    GGM
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROTROL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
    Device Description
    HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available. HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
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    K Number
    K152553
    Device Name
    CueSee Hypoxic
    Manufacturer
    EUROTROL B.V.
    Date Cleared
    2016-04-22

    (227 days)

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

    EUROTROL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).
    Device Description
    CueSee® Hypoxic is prepared from a stroma-free bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee® Hypoxic contains no preservatives, viscosity adjusters or other additives that might adversely effect electrode measurements. CueSee® Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution. CueSee® Hypoxic is packed in a carton box containing 5 ampules.
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    K Number
    K131595
    Device Name
    EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
    Manufacturer
    EUROTROL B.V.
    Date Cleared
    2013-07-26

    (53 days)

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

    EUROTROL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eurotrol GAS-ISE Hct QC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hct QC is for in vitro diagnostic use only. Eurotrol GAS-ISE Hct LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hct LVM is for in vitro diagnostic use only.
    Device Description
    Eurotrol GAS-ISE Hct QC quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer. Eurotrol GAS-ISE Hct QC is a non-hazardous aqueous solution that contains no biological materials. Eurotrol GAS-ISE Hct QC provides three (3) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct QC is packed in a carton box containing 10 ampules of a separate level. Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct LVM quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides five (5) distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer. Eurotrol GAS-ISE Hct LVM is a non-hazardous aqueous solution that contains no biological materials. Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct LVM is packed in a carton box containing a set of 5 ampules; one ampule of each level.
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    K Number
    K121467
    Device Name
    EUROTROL HEMATOCRIT CONTROL
    Manufacturer
    EUROTROL B.V.
    Date Cleared
    2013-05-10

    (358 days)

    Product Code
    GLK
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROTROL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only. epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.
    Device Description
    Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit. Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System. Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box. The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html
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    K Number
    K121468
    Device Name
    EUROTROL GAS-ISE METABOLITES
    Manufacturer
    EUROTROL B.V.
    Date Cleared
    2012-06-22

    (36 days)

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

    EUROTROL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eurotrol GAS-ISE Metabolites Eurotrol GAS-ISE Metabolites is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol GAS-ISE Metabolites was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. Eurotrol GAS-ISE Metabolites is also developed to verify calibration, operating temperature and other performance characteristics. epoc Calibration Verification Fluids epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. epoc Calibration Verification Fluids was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. epoc Calibration Verification Fluids is also developed to verify calibration, operating temperature and other performance characteristics.
    Device Description
    Eurotrol GAS-ISE Metabolites and epoc Calibration Fluids are assayed blood gas, electrolyte and metabolite reference materials, to venify the precision and accuracy of the epoc@ Blood Analysis System. Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids are filled in 3 mL clear glass ampules. Eurotrol GAS-ISE Metabolites provides three different physiologically relevant levels. epoc Calibration Verification Fluids provides five different physiologically relevant levels. 10 ampules of the same level of Eurotrol GAS-ISE Metabolites are packed in a carton box. 5 ampules, 1 ampule per level, of epoc Calibration Fluids are packed in a carton box. A product insert with Intended Use is inserted in each product box of GAS-ISE Metabolites and epoc Calibration Verification Fluids.
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    K Number
    K060215
    Device Name
    ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002
    Manufacturer
    EUROTROL B.V.
    Date Cleared
    2006-03-24

    (56 days)

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

    EUROTROL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlbuTrol is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Urine Albumin and HemoCue® Albumin 201 systems.
    Device Description
    AlbuTrol is an assayed urine albumin control material. AlbuTrol control material is filled of in dropper bottles. Each dropper bottle contains 1.0 mL human urine with a specific amount of human albumin. AlbuTrol provides two physiologically relevant levels covering the clincally interesting ranges of urine albumin: ~25 mg/L albumin and ~75 mg/L aboumin. The assigned values of each batch are printed on both the carton box and the dropper bottles. AlbuTrol is packed in carton boxes. Each carton box contains 2 dropper bottles of the same level on a carton tray. An insert with Intended Use is packed in each box of album of the
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