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510(k) Data Aggregation
K Number
K040579Device Name
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
Manufacturer
CHOLESTECH CORP.
Date Cleared
2004-06-18
(106 days)
Product Code
DCK
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
CHOLESTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of CRP in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Device Description
The Cholestech LDX System combines immunoassay and solid-phase technology to measure CRP. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX hs-CRP cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The resultant color in the reaction is measured by reflectance photometry. A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading to the CRP concentration in mg/L.
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K Number
K032027Device Name
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
Manufacturer
CHOLESTECH CORP.
Date Cleared
2003-09-05
(66 days)
Product Code
CIS
Regulation Number
862.1100Why did this record match?
Applicant Name (Manufacturer) :
CHOLESTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cholestech LDX aspartate aminotransferase (AST) test is for the in vitro quantitative determination of AST in whole blood or serum on the Cholestech LDX Analyzer. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis), and heart diseases.
Device Description
The Cholestech LDX System combines enzymatic methodology and solid-phase technology to measure AST. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX AST cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the AST reaction pad. The Cholestech LDX Analyzer measures Aspartate aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. 12- Aspartic acid aminotransferase catalyzes the transfer of amino groups from L-Aspartic acid to alpha-Ketoglutarate producing oxaloacetate and glutamate. Oxaloacetate Decarboxylase converts the Oxaloacetate to Pyruvate by the removal of CO2. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the AST concentration of the sample. The resultant color in the reaction is measured by reflectance photometry. A brown magnetic stripe on each cassette contains the calibration required for the Cholestech LDX Analyzer to convert the reflectance reading to the AST concentration in U/L. 37°C.
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K Number
K991834Device Name
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
Manufacturer
CHOLESTECH CORP.
Date Cleared
1999-09-09
(104 days)
Product Code
CKD
Regulation Number
862.1030Why did this record match?
Applicant Name (Manufacturer) :
CHOLESTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cholestech L·D·X Alanine aminotransferase Test (ALT) is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L.D.X Analyzer.
Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Device Description
The Cholestech L·D·X Alanine Aminotransferase Test (ALT) combines an enzymatic methodology and a solid-phase technology to measure ALT in whole blood or serum. Blood from a fingerstick is collected into a lithium heparin coated capillary tube (venous whole blood serum is also acceptable) and dispensed into a L·D·X cassette. The cassette is then placed into the Cholestech L·D·X where a unique system separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the ALT reaction pad.
The Cholestech L•D•X Analyzer measures alanine aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. Alanine aminotransferase catalyzes the transfer of amino groups from L-Alanine and α-Ketoglutarate to pyruvate and glutamate. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the ALT concentration of the sample. The resultant color in the reaction is measured by reflectance photometry.
L-Alanine + α -Ketoglutarate Alanine Aminotransferase → Pyruvate + Glutamate
Pyruvate + Phosphate + O2 + H2O Pyruvate Oxidase → Acetylphosphate + CO2 + H2O2
Indicator + H2O2 Peroxidase → Colored Blue Dye + H2O
A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech L•D•X Analyzer to convert the reflectance reading to the ALT concentration in U/L at 37° C.
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K Number
K972012Device Name
CHOLESTECH BUN/CREATININE TEST SYSTEM
Manufacturer
CHOLESTECH CORP.
Date Cleared
1997-07-24
(55 days)
Product Code
CDN, JFY
Regulation Number
862.1770Why did this record match?
Applicant Name (Manufacturer) :
CHOLESTECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative determination of Blood Urea Nitrogen and creatinine in whole blood. Creatinine values are used as indications of renal function. Blood Urea Nitrogen values are valuable in the diagnosis of renal diseases. For professional in vitro diagnostic use only.
Device Description
Not Found
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