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Found 4 results
510(k) Data Aggregation
K Number
K051969Device 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
862.1165Why did this record match?
Product Code :
CHQ
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
K032199Device Name
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
Manufacturer
ESA, INC.
Date Cleared
2004-01-30
(196 days)
Product Code
CHQ, CHO
Regulation Number
862.1165Why did this record match?
Product Code :
CHQ
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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K Number
K972167Device Name
PLASMA CATECHOLAMINE KIT
Manufacturer
BIOANALYTICAL SYSTEMS, INC.
Date Cleared
1997-08-04
(56 days)
Product Code
CHQ
Regulation Number
862.1165Why did this record match?
Product Code :
CHQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Catecholamine test system is a device intended to determine whether a group of similar compounds epinephrine and norepinephrine are present in plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma.
Device Description
The BAS Plasma Catecholamine Kit employs liquid chromatography with electrochemical detection to separate and quantitate epinephrine (E) and norepinephrine (NE) in human plasma under isocratic conditions as defined in the package insert. BAS provides the mobile phase for the elution of these analytes from the liquid chromatography column, which is also provided, as well as critical reagents for sample preparation. There is one complete start-up kit as well as one accessory replacement kit which will be offered for sale. The accessory replacement kit contains replacement reagents and mobile phase for sample preparation and analysis. The kit is designed for invitro applications only. All reagents and kit supplies contain the appropriate warnings as to irritants, corrosiveness or toxicity, etc. The Plasma Catecholamine Kit is not used in any way to sustain human life or to prevent impairment of human health. Therefore, the kit poses no safety hazard to the patients.
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K Number
K963938Device Name
MODEL 5500 CEAS
Manufacturer
ESA, INC.
Date Cleared
1996-12-26
(86 days)
Product Code
CHQ
Regulation Number
862.1165Why did this record match?
Product Code :
CHQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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