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510(k) Data Aggregation

    K Number
    K191589
    Device Name
    Calprest, EasyCal
    Manufacturer
    Eurospital S.p.A.
    Date Cleared
    2019-07-10

    (26 days)

    Product Code
    NXO
    Regulation Number
    866.5180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eurospital S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calprest is a quantitative ELISA for detecting concentration of fecal calprest can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.
    Device Description
    Calprest® is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of polyclonal antibody against calprotectin. Calprotectin present in the diluted sample is bound by the antibody adsorbed to the surface of the plastic well. The enzyme conjugated antibody binds to the captured antigen and subsequently the enzyme catalyzes the conversion of the substrate to a colored product. The intensity of the color is proportional to the amount of conjugate bound, and thus to the amount of captured calprotectin. Concentration of calprotectin in the samples is calculated using the provided standards. EasyCal is a single-use device for stool sample pre-analytical processing that allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprest® and Calprest®NG assays. The device consists of a tube, containing 2.8 ml of extraction solution, a stick shaped with seven grooves for collecting the sample. The upper end is made up by two components which can be removed by opposite rotations. The screw cap (white) connected to the shaped stick traps the sample excess and can be then removed by counter-clockwise rotation. Once the extraction procedure has been completed, the sample can be transferred to an automated ELISA instrumentation, placing it directly into the sample rack. EasyCal allows an easy, reliable and reproducible way to sample from primary containers and analyze the extract directly from the device, without the need to weight the stool sample.
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    K Number
    K191592
    Device Name
    CalprestNG, EasyCal
    Manufacturer
    Eurospital S.p.A.
    Date Cleared
    2019-07-10

    (26 days)

    Product Code
    NXO
    Regulation Number
    866.5180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eurospital S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CalprestNG is a quantitative ELISA for detecting concentration of fecal calprotectin. CalprestNG can in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.
    Device Description
    Calprest®NG is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of antibodies against calprotectin. Calprotectin present in the diluted sample is bound by the antibody adsorbed to the surface of the plastic well. The enzyme conjugated antibody binds to the captured antigen and subsequently the enzyme catalyzes the conversion of the substrate to a colored product. The intensity of the color is proportional to the amount of conjugate bound, and thus to the amount of captured calprotectin. Concentration of calprotectin in the samples is calculated using the provided standards. EasyCal is a single-use device for stool sample pre-analytical processing that allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprest® and Calprest®NG assays. The device consists of a tube, containing 2.8 ml of extraction solution, a stick shaped with seven grooves for collecting the sample. The upper end is made up by two components which can be removed by opposite rotations. The screw cap (white) connected to the shaped stick traps the sample excess and can be then removed by counter-clockwise rotation. Once the extraction procedure has been completed, the sample can be transferred to an automated ELISA instrumentation, placing it directly into the sample rack. EasyCal allows an easy, reliable and reproducible way to sample from primary containers and analyze the extract directly from the device, without the need to weight the stool sample.
    Ask a Question
    K Number
    K160447
    Device Name
    Calprest NG
    Manufacturer
    EUROSPITAL S.P.A.
    Date Cleared
    2016-11-10

    (267 days)

    Product Code
    NXO
    Regulation Number
    866.5180
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROSPITAL S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calprest®NG is a quantitative ELISA for detecting concentration of fecal calprotectin, which can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's disease and ulcerative colitis, and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.
    Device Description
    Calprest®NG is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of antibodies against calprotectin present in the diluted sample is bound by the antibody adsorbed to the surface of the plastic well. The enzyme conjugated antibody binds to the captured antigen and subsequently the enzyme catalyzes the conversion of the substrate to a colored product. The intensity of the color is proportional to the amount of conjugate bound, and thus to the amount of captured calprotectin. Concentration of calprotectin in the samples is calculated using the provided standards.
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    K Number
    K130945
    Device Name
    CALPREST
    Manufacturer
    EUROSPITAL S.P.A.
    Date Cleared
    2014-01-16

    (287 days)

    Product Code
    NXO
    Regulation Number
    866.5180
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROSPITAL S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calprest® is a quantitative ELISA for detecting the concentration of fecal calprest@can be used as an in-vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other laboratory findings.
    Device Description
    Calprest® is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of polyclonal antibody against calprotectin present in the diluted sample is bound by the antibody adsorbed to the surface of the plastic well. The enzyme conjugated antibody binds to the captured antigen and subsequently the enzyme catalyzes the conversion of the substrate to a colored product. The intensity of the color is proportional to the amount of conjugate bound, and thus to the amount of captured calprotectin. Concentration of calprotectin in the samples is calculated using the provided standards.
    Ask a Question

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