Search Results
Found 5 results
510(k) Data Aggregation
K Number
K120664Device Name
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
Manufacturer
ABAXIS, INC.
Date Cleared
2012-04-24
(50 days)
Product Code
JGY
Regulation Number
862.1705Why did this record match?
Product Code :
JGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.
Device Description
The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Triglycerides - Capillary Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
Ask a Question
K Number
K023639Device Name
PICCOLO TRIGLYCERIDES TEST SYSTEM
Manufacturer
ABAXIS, INC.
Date Cleared
2003-01-24
(86 days)
Product Code
JGY
Regulation Number
862.1705Why did this record match?
Product Code :
JGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piccolo Triglycerides Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.
Device Description
The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analvzer. Alternately, the disc mav also be used with serum.
Ask a Question
K Number
K000586Device Name
BIOSCANNER TRIGLYCERIDES TEST STRIPS
Manufacturer
POLYMER TECHNOLOGY SYSTEMS, INC.
Date Cleared
2000-07-03
(132 days)
Product Code
JGY
Regulation Number
862.1705Why did this record match?
Product Code :
JGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K991894Device Name
BIOSCANNER TRIGLYCERIDES TEST STRIPS
Manufacturer
POLYMER TECHNOLOGY SYSTEMS, INC.
Date Cleared
2000-05-24
(356 days)
Product Code
JGY, CDT
Regulation Number
862.1705Why did this record match?
Product Code :
JGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.
Device Description
Triglycerides are hydrolyzed by lipoprotein lipase to glycerol and fatty acid. Glycerol is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP) forming glycerol-3-phosphate and adenosine-5-diphosphate (ADP). The glycerol-3phosphate is oxidized by glycerophosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. In the presence of peroxide, peroxidase catalyzes the coupling of 4-AAP (4-aminoantipyrine) with an N,N-disubstituted aniline to form a quinoneimine dye.
Ask a Question
K Number
K971005Device Name
TRIGLYCERIDES
Manufacturer
DERMA MEDIA LAB., INC.
Date Cleared
1997-04-21
(33 days)
Product Code
JGY
Regulation Number
862.1705Why did this record match?
Product Code :
JGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1