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510(k) Data Aggregation
K Number
K961276Device Name
GASTRIN EIA MODEL 06B-555017
Manufacturer
Date Cleared
1996-05-30
(57 days)
Product Code
Regulation Number
862.1325Why did this record match?
Applicant Name (Manufacturer) :
BIOSYN LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Gastrin EIA is for quantitative measurement of Gastrin in human serum. Gastrin is a polypeptide hormone produced and secreted by the G cells of the gastric antral mucosa. It occurs in the circulation in several different forms, among those Gastrin-17 and Gastrin-34, sulphated and nonsulphated. The determination of serum gastrin can be used as an aid in the diagnosis of Zollinger-Ellison Syndrome, gastric cancers, achlorhydia ( with or without pernicious anaemia), G-cell hyperplasia and duodenal ulcer. In all of these clinical conditions the serum gastrin concentration is elevated. Normal fasting serum gastrin concentrations are below 100 pg/ml, while fasting serum levels in the above conditions are significantly higher. Measurement of serum gastrin may also be used to monitor patients with previous gastric surgery. Treatment with histamine H2 receptor antagonists and with antisecretory drugs may cause a rise in the serum gastrin concentration. Quantification of serum gastrin can then be used to monitor treatment with these drugs.
Device Description
Gastrin EIA is an in vitro enzyme immunoassay for the quantitative measurement of gastrin in human serum. Gastrin in serum is assayed by a competition reaction using an antibody raised against a gastrin immunogen. Gastrin in standards and samples compete with immobolised Gastrin in binding the antigastrin antibody. The extent of antibody binding to the solid phase is inversely related to the concentration of Gastrin in the standard or patient sample.
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