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510(k) Data Aggregation
K Number
K062503Device Name
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
Manufacturer
Date Cleared
2007-01-19
(147 days)
Regulation Number
862.1177Why did this record match?
Product Code :
KWW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Catachem, Inc. Bile Acids assay is an In-Vitro diagnostic enzymatic assay for the quantitative determination of total bile acids in human serum. Measurement of bile acids in human serum, and increased reported levels are representative of specific liver disease. For In-Vitro diagnostic use only
Bile Acids Calibrator. (For In-Vitro diagnostic use only) The bile acids assay contains a calibrator designed for the calibration of the Bile Acids method.
Bile Acids Controls (For In-Vitro diagnostic use only) The bile acids assay also contains control Level-I and control Level-II. These controls are designed to monitor the performance of the Bile Acids assay.
Device Description
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K Number
K051714Device Name
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
Manufacturer
Date Cleared
2005-12-07
(163 days)
Regulation Number
862.1177Why did this record match?
Product Code :
KWW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Total Bile Acids Assay is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum samples. Total bile acids are metabolized in the liver and serve as a marker for normal and abnormal liver function. Serum total bile acids are increased in patients with liver disease.
Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to be used with the assay for the quantitative determination of TBA in serum.
Total Bile Acids Assay has control design to be used with the assay for the quantitative determination of TBA in serum.
Device Description
The Diazyme's Total Bile Acids assay is a clinical test kit, intended for quantitative determination of total bile acids in serum by an enzymatic method.
The Diazyme's Total Bile Acids assay is comprised of Reagent 2, and a calibrator.
The reagents of the assay kit are stable liquid formulation that allows ease of use coupled with enhanced performance characteristics. In the presence of Thio-NAD, the enzyme 3ox-hydroxysteroid dehydrogenase (3-a-HSD) converts bile acids to 3-keto steroids and Thio-NADH. The reaction is reversible and 3-0-HSD can convert 3-keto steroids and Thio-NADH to bile acids and Thio-NAD. In the presence of excess NADH, the enzyme cycling occurs efficiently and the rate of formation of Thio-NADH is determined by measuring specific change of absorbance at 405nm.
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K Number
K970120Device Name
BILE ACIDS REAGENT SET
Manufacturer
Date Cleared
1997-03-24
(69 days)
Product Code
Regulation Number
862.1177Why did this record match?
Product Code :
KWW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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