(122 days)
Oxoid Pylori Test Kit is a rapid latex agglutination test for the qualitative detection of Helicobacter onlori total antibodies in serum as an aid in the diagnosis of infections by H. pylori. The product is intended for use to test patients 18 years and older, with symptoms of gastro-intestinal disorders.
rapid latex agglutination test
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a 510(k) clearance letter from the FDA for the Oxoid Pylori Test Kit, focusing on its substantial equivalence to a predicate device and its intended use. It does not contain the detailed study information you are requesting.
§ 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).