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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
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K032199
    Device Name
    ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
    Manufacturer
    ESA, INC.
    Date Cleared
    2004-01-30

    (196 days)

    Product Code
    CHQ, CHO
    Regulation Number
    862.1165
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    Matched: '862.1165'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESA Plasma Free Metanephrine Analysis Kit is intended for use in clinical laboratories that hold a CLIA certificate to perform tests of high complexity to measure endogenous free levels of the metanephrines (normetanephrine and metanephrine) in plasma using high performance liquid chromatography with electrochemical detection. The analysis of these analytes is used in the differential diagnosis of adult male and female patients with pheochromocytoma. For In Vitro Diagnostic Use Only.
    Device Description
    The ESA Free Plasma Motanephrine Analysis Kit consists of reagents for the extraction of metanephrines (normetanephrine and metanephrine) sufficient for 100 plasma samples. Sample clean-up is achieved with ion exchange solid phase extraction. The final extracts are ovaporated to dryness, reconstituted and analyzed via reversed phase ion-pair high performance liquid chromatography and electrochemical detection using the ESA CoulArray® detector. The multichannel electrode system oxidizes the metanepluines and the internal standard, 4-Hydroxy-3-mothoxybenzlamine (HMBA), followed by reduction at a downstream electrode. Total chromatographic run time is approximately 28 minutes per sample. Quantitative data analysis and report generation is performed using ESA CoulArray for Windows Data Station.
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