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510(k) Data Aggregation

    K Number
    K022176
    Device Name
    ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
    Manufacturer
    ORION DIAGNOSTICA, DIV. ORION CORP.
    Date Cleared
    2002-12-03

    (153 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL

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

    Orion Diagnostica High Sensitivity CRP (HS-CRP) is an in vitro diagnostic assay intended for the quantification of low concentrations (ca. 0.25 - 10.0 mg/l) of C-reactive protein (CRP) in human serum or plasma (EDTA or heparin) by means of particle enhanced immunoturbidimetry using a Hitachi 911 or 917 analyzer. The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Orion Diagnostica High Sensitivity CRP (HS-CRP)" device. It states that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use for quantifying C-reactive protein in human serum or plasma.

    However, the document does not contain the detailed information requested regarding:

    • Acceptance criteria and reported device performance (in a table format).
    • Sample size and provenance for test sets.
    • Number and qualifications of experts for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) study results or effect size.
    • Standalone algorithm performance.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • Sample size for training sets.
    • Ground truth establishment for training sets.

    This type of information is typically found in the 510(k) submission document itself, which is a much more extensive technical file than the clearance letter provided here. The clearance letter only confirms that the FDA has reviewed the submission and found the device substantially equivalent.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and study details based solely on the provided text.

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