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510(k) Data Aggregation

    K Number
    K212559
    Device Name
    CardioPhase® hsCRP
    Manufacturer
    Siemens Healthcare Diagnostics Products GmbH
    Date Cleared
    2022-12-16

    (490 days)

    Product Code
    NQD
    Regulation Number
    866.5270
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K033908
    Why did this record match?
    Reference Devices :

    K033908

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CardioPhase® hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

    Device Description

    The CardioPhase hsCRP assay is an in vitro diagnostic reagent for the quantitative determination C-reactive protein, in human serum, and heparinized and EDTA plasma by means of particle-enhanced immunoassay determination. Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

    AI/ML Overview

    This document describes the CardioPhase® hsCRP device, a C-reactive protein immunological test system, and a Special 510(k) submission for a change in its reference standard material from ERM-DA470 to ERM-DA474/IFCC.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state numerical acceptance criteria for all performance characteristics, but rather describes the studies performed and their satisfactory outcomes which imply meeting internal acceptance limits. For instance, for linearity, the stated ranges confirm the measuring range, implying that the observed linearity falls within acceptable deviations. For matrix comparison, high correlation coefficients and slopes close to 1 with intercepts close to 0 indicate acceptable equivalence.

    Performance CharacteristicAcceptance Criteria (Implicit/Explicit)Reported Device Performance
    Detection CapabilitiesLimit of Blank (LoB): Values below the respective Limit of Quantitation (LoQ).
    Limit of Detection (LoD): Greater than LoB and equal to or below LoQ.
    Limit of Quantitation (LoQ): An imprecision goal of less than 20% CV. (Specific numerical LoB/LoD not provided as acceptance criteria, but derived from the study.)LoB: All results measured on blank samples yielded results below the respective LoQ.
    LoD: Calculated parametrically, greater than LoB and equal to or below LoQ.
    LoQ: Set to 0.094 mg/L based on the sample/instrument/reagent lot combination with the highest imprecision observed in the study (
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