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510(k) Data Aggregation

    K Number
    K043125
    Device Name
    ORION DIAGNOSTICA UNIQ PINP RIA
    Manufacturer
    ORION DIAGNOSTICA OY
    Date Cleared
    2005-05-04

    (173 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ORION DIAGNOSTICA UNIQ PINP RIA

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

    Orion Diagnostica UniQ™ PINP RIA is a quantitative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to an FDA 510(k) clearance for a diagnostic device, the Orion Diagnostica UniQ™ PINP RIA. However, it does not contain any information regarding acceptance criteria, device performance, specific study details (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or training set details.

    The document is a clearance letter and an "Indications for Use" statement. It confirms that the device has been found substantially equivalent to a predicate device but does not present the data from the studies that led to this determination.

    Therefore, I cannot provide the requested information based on the given input.

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