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510(k) Data Aggregation

    K Number
    K201256
    Device Name
    Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
    Manufacturer
    Procise Diagnostics
    Date Cleared
    2022-11-04

    (907 days)

    Product Code
    DCK
    Regulation Number
    866.5270
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    Applicant Name (Manufacturer) :

    Procise Diagnostics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human serum. The test is carried out by means of the ProciseDx Analyzer. Measurement of CRP aids in evaluation of injury to body tissues, inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point of care use.
    Device Description
    The Procise CRP assay is a homogeneous sandwich immunoassay assay that uses a fluorescence resonance energy transfer (FRET) signal to detect and quantify CRP. FRET is a process in which a donor molecule, in an excited state, transfers excitation energy to an acceptor fluorophore when the two are brought into close proximity. Upon excitation at a characteristic wavelength the energy absorbed by the donor is transferred to the acceptor, which in turn emits light energy. The level of light emitted from the acceptor fluorophore is directly proportional to the degree of donor/acceptor complex formation. The Procise CRP assay format is designed as a competitive format. A monoclonal anti-CRP antibody and exogenous CRP antigen are labeled with donor and acceptor fluorophores, respectively. The monoclonal antibody specific for CRP is labelled with the donor fluorophores and the CRP antigen is labelled with the acceptor fluorophore. Similar to other competitive assay formats, as the concentration of CRP increases a proportional decrease in the signal is observed.
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