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510(k) Data Aggregation

    K Number
    K051969
    Device Name
    TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA
    Manufacturer
    IBL GMBH
    Date Cleared
    2005-10-03

    (75 days)

    Product Code
    CHQ
    Regulation Number
    862.1165
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA

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

    The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination r fre lDE Suttonnines adrenaline (epinephrine), noradrenaline (norepinephrine) and/or dopamine (either separate or combined) in human plasma and urine. The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of r he Galecholanine tool hits are asserally of the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry but this document does not contain the requested information. The document is a 510(k) premarket notification letter from the FDA regarding several RIA test kits for catecholamines. While it mentions the device names, regulation numbers, and intended use, it does not provide details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the scientific study reports or summary of safety and effectiveness, which are not included here.

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