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510(k) Data Aggregation

    K Number
    K232057
    Device Name
    BÜHLMANN fCAL® turbo and CALEX® Cap
    Manufacturer
    BÜHLMANN Laboratories AG
    Date Cleared
    2024-02-06

    (210 days)

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

    BÜHLMANN Laboratories AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings. The BÜHLMANN CALEX® Cap is a single use tube intended for the preparation of human stool samples to be used with the BUHLMANN fCAL® turbo.
    Device Description
    The BÜHLMANN fCAL® turbo, a particle-enhanced turbidimetric immunoassay (PETIA), is performed using patient stool extracts collected without preservatives. Calprotectin within the sample extract mediates immunoparticle agglutination; sample turbidity is proportional to calprotectin concentration. The detected light absorbance allows quantification of calprotectin concentration via interpolation of an established calibration curve. The assay is validated for use on clinical chemistry analyzers such as the Roche cobas® c501/c502 platforms. The BÜHLMANN fCAL® turbo Reagent Kit is to be used in conjunction with the BÜHLMANN fCAL® turbo Calibrator Kit and BÜHLMANN fCAL® turbo Control Kit, which are available separately. Sample extracts may be prepared using manual weighing extraction methods or the CALEX® Cap. The CALEX® Cap is a single use tube filled with extraction buffer. The sampling pin houses a dosing tip which is used to obtain sufficient stool sample for the extraction process. The extraction method leads to stool specimen extracts which can be measured directly using the BÜHLMANN fCAL® turbo assay.
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