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510(k) Data Aggregation
K Number
K972609Device Name
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
Manufacturer
BIO-RAD
Date Cleared
1997-08-06
(26 days)
Product Code
LCQ, LCB
Regulation Number
862.3450Why did this record match?
Product Code :
LCQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VARIANT Express Glycohemoglobin Program is intended for the separation and area percent determination of glycohemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC).
Device Description
The Bio-Rad VARIANT Express Glycohemoglobin Program is designed for use on the Bio-Rad VARIANT Express Instrument. The analytical system, consisting of instrument, software and reagent kit, provides an assay for the separation and percent determination of glycohemoglobin in whole blood. The VARIANT Express Glycohemoglobin Program is for use on the fully automated VARIANT Express analyzer. The analytical system of instrument and reagent kit provides a means of measuring a mixture of hemoglobins, each formed by the non-enzymatic attachment of circulating blood glucose to a receptive amino acid site on the hemoglobin molecule (HbAo). Attachment of glucose to hemoglobin is achieved in a two step process: formation of an unstable aldimine (Schiff base) intermediate followed by production of a stable ketoamine linkage. Formation of the Schiff base intermediate is a reversible reaction and is influenced by short-term blood glucose fluctuations. In contrast, conversion of the Schiff base intermediate to the "ketoamine" products (Total GHb) is much slower and irreversible. The percentage of total glycated hemoglobin in whole blood is dependent upon the level of sustained blood glucose and is indicative of mean blood glucose over the lifetime of red blood cells (~120 days). Thus, monitoring of total GHb levels has become a routine test for the long-term management of patients with diabetes mellitus.
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K Number
K955569Device Name
INNOFLUOR GENTAMICIN ASSAY SYSTEM
Manufacturer
OXIS INTL., INC.
Date Cleared
1996-02-09
(65 days)
Product Code
LCQ
Regulation Number
862.3450Why did this record match?
Product Code :
LCQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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