(218 days)
The Shield Helico G2 kit is a qualitative indirect enzyme immunoassay for the detection of the IgG class of antibodies for Helicobacter pylori (H pylori) in human serum or plasma (EDTA or Heparin ). The test is intended as an aid in the diagnosis of H pylori infection in adults and is not definitive in isolation. Antibodies represent one parameter in a multi-criteria diagnostic process.
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I am sorry but this document does not contain the requested information. The document is a 510(k) clearance letter from the FDA for a device called "Shield Helico G2 Elisa Kit." It mainly discusses regulatory aspects, such as substantial equivalence, classification, and general controls. It does not provide details about acceptance criteria, study methodologies, sample sizes, or ground truth establishment for the device's performance.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).