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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
ESA, INC.
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
K971640Device Name
LEADCARE BLOOD LEAD TESTING SYSTEM
Manufacturer
ESA, INC.
Date Cleared
1997-09-09
(130 days)
Product Code
DOF
Regulation Number
862.3550Why did this record match?
Applicant Name (Manufacturer) :
ESA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LEADCARE™ Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The LEADCARE System is suitable for use in a physician office laboratory environment (POL).
Device Description
Not Found
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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?
Applicant Name (Manufacturer) :
ESA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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