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510(k) Data Aggregation
K Number
K171247Device Name
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
Manufacturer
Epocal Inc.
Date Cleared
2018-01-17
(264 days)
Product Code
CDS
Regulation Number
862.1770Why did this record match?
Product Code :
CDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.
Device Description
The epoc Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc System is comprised of 3 major subsystems: epoc Host, epoc Reader and epoc BGEM Test Card. The main accessory used with the epoc System includes the epoc Care-Fill Capillary Tubes used to collect and introduce capillary blood samples into the epoc Test Card.
The epoc Blood Analysis System was previously cleared for prescription use to quantitate pH, pCO2, pO2, Na, K, iCa, Cl, Glu, Lact, Crea, and Hct in arterial, venous, and capillary blood samples per k061597, k090109, k092849, k093297, and k113726. This premarket notification submission adds blood urea nitrogen (BUN) and total carbon dioxide (TCO2) quantitation to the epoc BGEM Test Card and Blood Analysis System.
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K Number
K040973Device Name
BUN REAGENT
Manufacturer
GENCHEM, INC.
Date Cleared
2004-12-27
(257 days)
Product Code
CDS
Regulation Number
862.1770Why did this record match?
Product Code :
CDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.
Device Description
The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.
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K Number
K033056Device Name
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
Manufacturer
DIAMOND DIAGNOSTICS, INC.
Date Cleared
2004-01-30
(123 days)
Product Code
CDS
Regulation Number
862.1770Why did this record match?
Product Code :
CDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative determination of urea nitrogen in serum, plasma, and urine on Beckman Synchron CX & CX® Delta Analyzers. BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases.
Device Description
Urea nitrogen concentration is determined by an enzymatic conductivity method employing a Beckman Conductivity Electrode. Electronic circuits determine the rate of increase in conductivity, which is directly proportional to the concentration of BUN in the sample. Mission uses a similar composition, description and packaging as that used by the OEM in its products.
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