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510(k) Data Aggregation
K Number
K980883Device Name
N-ASSAY GLU-UL
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1998-09-03
(178 days)
Product Code
CFR
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the N-ASSAY Glu-UL Reagent is for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. For in vitro diagnostic use only.
Device Description
The N-ASSAY Glu-UL reagent is based on an enzymatic hexokinase/glucose-6phosphate dehydrogenase method, shows good correlation with similar glucose reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is a convenient ready-to-use liquid type reagent.
In this method, serum D-glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-Phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The increase in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of the NADPH, is directly proportional to the glucose concentration in the sample.
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K Number
K981276Device Name
N-ASSAY L D-BIL
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1998-05-01
(23 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the N-ASSAY L D-BIL Reagent is for the quantitative measurement of direct bilirubin in human serum in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.
Device Description
The N-ASSAY L D-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar direct bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. In this method, a serum sample containing direct bilirubin is mixed with the reagent containing sodium nitrite. Direct billrubin is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.
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K Number
K981289Device Name
N-ASSAY L T-BIL
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1998-04-27
(19 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the N-ASSAY L T-BIL Reagent is for the quantitative determination of serum Total Bilirubin in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.
Device Description
The N-ASSAY L T-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar Total Bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.
In this method, a serum sample containing total bilirubin is mixed with the reagent containing sodium nitrite. Total bilirubin (direct bilirubin) is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the total billinubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.
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K Number
K980900Device Name
N-ASSAY CPK-L
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1998-03-26
(16 days)
Product Code
CGS
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the N-ASSAY CPK-L Reagent is for the quantitative determination of serum creatine phosphokinase (CPK) activity in human serum in the diagnosis and treatment of myocardial infarction and muscle diseases such as muscular dystrophy.
Device Description
The N-ASSAY CPK-L reagent is based on an optimized CPK kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar CPK reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. The N-ASSAY CPK-L reagent utilizes an enzymatic method. In this procedure, creatine phosphate is dephosphorylated by creatine phosphokinase (CPK) in the presence of adenosine disphosphate (ADP) to produce creatine and adenosine triphosphate (ATP). ATP is dephosphorylated by hexokinase in the presence of D-glucose to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate. Glucose-6-phosphate dehydrogenase specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 (sub) and can be detected spectrophotometrically. The increase per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of NADPH, is directly proportional to CPK activity in the sample.
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K Number
K980902Device Name
N-ASSAY L AST/GOT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1998-03-26
(16 days)
Product Code
CIT
Regulation Number
862.1100Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases. For in vitro diagnostic use only.
Device Description
The N-ASSAY L AST/GOT reagent is based on an the optimized enzymatic AST kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar AST reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.
In this procedure, L-Aspartic Acid and a-Ketoglutaric Acid are translated by aspartate aminotransferase (AST) to produce Oxalacetic Acid and Glutamic Acid. Oxalacetic Acid is reduced by Malic Dehydrogenase to produce Malic Acid with the concurrent oxidation of nicotinamide adenine dinucleotide reduced (NADH) to nicotinamide adenine dinucleotide (NAD). The NADH absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The decrease per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the decrease of NADH, is directly proportional to the AST activity in the sample.
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K Number
K971985Device Name
N-ASSAY TIA PLASMINOGEN TEST KIT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-10-20
(144 days)
Product Code
GGP, DDX
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-turbidimetric assay. Decreased levels of plasminogen are of clinical importance. Low levels of plasminogen are usually due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.
Device Description
N-Assay TIA Plasminogen Test Kit
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K Number
K972257Device Name
N-ASSAY TIA ANTITHROMBIN III TEST KIT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-10-20
(125 days)
Product Code
DDQ, JBQ
Regulation Number
864.7060Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-TII is also helpful in monitoring heparin therapy.
Device Description
Not Found
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K Number
K964292Device Name
N-ASSAY TIA APO A1 TEST KIT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-08-01
(276 days)
Product Code
DER
Regulation Number
866.5580Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow. of apoprotein A-l is useful in the diagnosis of atherosclerosis.
Device Description
Not Found
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K Number
K964294Device Name
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-08-01
(276 days)
Product Code
DER
Regulation Number
866.5580Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits. which are immuno turbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.
Device Description
Not Found
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K Number
K964296Device Name
N-ASSAY TIA APO B TEST KIT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-08-01
(276 days)
Product Code
DER
Regulation Number
866.5580Why did this record match?
Applicant Name (Manufacturer) :
CRESTAT DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.
Device Description
Not Found
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