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510(k) Data Aggregation
K Number
K102568Device Name
URIC ACID MODEL 3P39
Manufacturer
ABBOTT LABORATORIES
Date Cleared
2011-05-06
(241 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARCHITECT 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.
Device Description
The Uric Acid assay is an in vitro diagnostic assay for use on the ARCHITECT c8000 System for the quantitative determination of uric acid in human serum, plasma, or urine using a uricase methodology. The Uric Acid assay is a two-part reaction. Uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide (H2O2). The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-sulfopropyl)-3-methoxy-5methylanaline (HMMPS) in the presence of peroxidase (POD) to yield a quinoneimine dye. The resulting change in absorbance at 604 nm is proportional to the uric acid concentration in the sample.
The two-part (R1/R2) configuration of this assay allows reduction of interference from ascorbic acid by inclusion of ascorbic oxidase in the R1 portion of the assay.
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K Number
K062862Device Name
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
2007-04-06
(193 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers
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
Not Found
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K Number
K040467Device Name
VITALAB URIC ACID REAGENT
Manufacturer
CLINICAL DATA, INC.
Date Cleared
2004-03-08
(13 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used for 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
The Vitalab Uric Acid Reagent is a two-part for use with the Vitalab Selectra Analyzer. This reagent determines uric acid through enzymatic oxidation by uricase linked to a Trinder indicator reaction utilizing N-ethyl-N-(bydroxy-3sulfopropyl)-toluidine (TOOS) and 4-aminoantipyrine.
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K Number
K031044Device Name
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
Manufacturer
CLINICAL DATA, INC.
Date Cleared
2003-07-15
(105 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Device Description
The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.
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K Number
K022096Device Name
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Manufacturer
BAYER DIAGNOSTICS CORP.
Date Cleared
2003-03-18
(264 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.
Device Description
Not Found
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K Number
K023550Device Name
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
Manufacturer
WIENER LABORATORIES S.A.I.C.
Date Cleared
2002-12-09
(48 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wiener lab. Uricostat enzimático AA Líquida. test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum 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 under treatment with cytotoxic drugs.
Device Description
End point method. The principle is based on the following reaction system: UOD Uric Acid + 2 H2O + O2- -> Allantoin + H2O2 + CO2 POD 2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------ The amount of uric acid is determined by measuring the absorbance of this pigment. UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone; 3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.
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K Number
K012038Device Name
JAS URIC ACID LIQUID REAGENT
Manufacturer
JAS Diagnostics, Inc.
Date Cleared
2001-08-21
(53 days)
Product Code
KNK, JHB
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers.
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.
Device Description
Not Found
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K Number
K010421Device Name
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
Manufacturer
WIENER LABORATORIES S.A.I.C.
Date Cleared
2001-04-13
(60 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993469Device Name
WAKO L-TYPE UA F TEST
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
1999-11-09
(27 days)
Product Code
KNK, JHB
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for measure uric acid in serum, plasma and are used in the obtain and urine. Measurements 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
The Wako L-Type UA F Test is an in vivo assay for the quantitative determination of uric acid in serum and plasma. The Wako L-Type UA F is a method utilizing uricase, N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS) and 4-aminoantipyrine.
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K Number
K991247Device Name
URIC ACID, MODEL UA112-01
Manufacturer
A.P. TOTAL CARE, INC.
Date Cleared
1999-05-25
(43 days)
Product Code
KNK
Regulation Number
862.1775Why did this record match?
Product Code :
KNK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uric Acid reagent, product No. UA112-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of Uric Acis in serum, or plasma.
Device Description
Not Found
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