Search Results
Found 7 results
510(k) Data Aggregation
K Number
K033278Device Name
RANDOX URIC ACID
Manufacturer
RANDOX LABORATORIES, LTD.
Date Cleared
2004-02-27
(140 days)
Product Code
CDO
Regulation Number
862.1775Why did this record match?
Product Code :
CDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is nonabsorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is measured using a bichromatic (293, 700nm) end-point technique.
Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs.
This application sheet has been developed for the Dade Dimension Clinical Chemistry Analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.
Device Description
The Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is nonabsorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is measured using a bichromatic (293, 700nm) end-point technique.
Ask a Question
K Number
K992798Device Name
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
1999-09-28
(40 days)
Product Code
CDO
Regulation Number
862.1775Why did this record match?
Product Code :
CDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum, plasma or urine on both automated and manual systems.
The Sigma Diagnostics INFINJTY™ Uric Acid Reagent is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by the device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Device Description
This reagent is based upon the methods of Trivedi and Kabasakalland with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).
The series of reactions involved in the assay system is as follows:
- Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1 .
Uric Acid + O2 + H2O _ Uricase _ Allantoin + CO2 + H2O2
- The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
HoOs + 4-AAP + TBHB Peroxidase \ Ouinoneimine + H2O
Ask a Question
K Number
K982251Device Name
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
1998-08-18
(53 days)
Product Code
CDO
Regulation Number
862.1775Why did this record match?
Product Code :
CDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum or urine on both automated and manual systems.
The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Device Description
This reagent is based upon the methods of Trivedi and Kabasakallan with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).
The series of reactions involved in the assay system is as follows:
- Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1.
Uric Acid + O2 + H2O Uricase > Allantoin + CO2 + H2O2
- The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
H2O2 + 4-AAP + TBHB Peroxidase > Quinoneimine + H2O
Ask a Question
K Number
K981766Device Name
URIC ACID
Manufacturer
ABBOTT LABORATORIES
Date Cleared
1998-06-19
(31 days)
Product Code
CDO
Regulation Number
862.1775Why did this record match?
Product Code :
CDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine. Measurements of uric acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Device Description
Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to vield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the uric acid concentration in the sample.
Ask a Question
K Number
K981189Device Name
URIC ACID
Manufacturer
ABBOTT LABORATORIES
Date Cleared
1998-05-07
(35 days)
Product Code
CDO
Regulation Number
862.1775Why did this record match?
Product Code :
CDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. Measurements of uric acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Device Description
Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 550 nm is proportional to the uric acid concentration in the sample.
Ask a Question
K Number
K971485Device Name
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Manufacturer
TRACE AMERICA, INC.
Date Cleared
1997-05-27
(34 days)
Product Code
CDO
Regulation Number
862.1775Why did this record match?
Product Code :
CDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for the In Vitro, quantitative determination of Uric Acid in human serum and urine for clinical diagnosis.
"This Uric Acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs", CFR 862.1775
Device Description
TRACE !!!ric Acid - DST Reagent
Ask a Question
K Number
K955752Device Name
OLYMPUS URIC ACID REAGENT
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1996-01-31
(43 days)
Product Code
CDO
Regulation Number
862.1775Why did this record match?
Product Code :
CDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1