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510(k) Data Aggregation
K Number
K041238Device Name
HELICOBACTER PYLORI IGG ELISA
Manufacturer
Date Cleared
2004-12-13
(216 days)
Product Code
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
BIOHIT PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Helicobacter pyloxi IgG ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human IgG class antibodies to Helicobacter pylori in serum and in EDTA or heparin-treated plasma. The test is intended to aid in the diagnosis of Helicobacter pylori infection in adult patients with clinical symptoms of gastritis. FOR INVITRO DIAGNOSTIC USE.
Device Description
The Helicobacter pylori IgG ELISA is an immunoassay to detect IgG antibodies to Helicobacter pylori. The assay requires a total of 90-minutes incubation. The test uses partially purified Helicobacter pylori bacterial antigen adsorbed to a solid phase microassay well. Prediluted test serum or plasma is added to each well and incubated for 30 minutes at 37℃. If Helicobacter pylori-specific IgG antibodies are present, they will bind to the antigen in the well. After the incubation, the wells are washed three times to remove any unbound serum or plasma. An HRP-conjugated monoclonal anti-human IgG is added to each well, and the test is incubated for 30 minutes at 37℃. If Helicobacter pylori antibody is present, it will bind to the antibody attached to the antigen on the well. The wells are washed again to remove any unbound conjugate. A TMB-substrate is added to each well and incubated for 30 minutes at room temperature (20-25°C). If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, the reaction is stopped with a Stop Solution and the color intensity is measured spectrophotometrically. The Helicobacter pylori IgG ELISA is highly sensitive for the detection of IgG antibodies to Helicobacter pvlori in serum or plasma samples.
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