(86 days)
The QUANTA Lite™ H. pylori IgG kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to H. pylori (Helicobacter pylori) in patient sera. This test is intended to aid in the diagnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease. This test is for in vitro diagnostic use.
enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to H. pylori (Helicobacter pylori) in patient sera.
The provided text is a 510(k) premarket notification letter from the FDA regarding the QUANTA Lite™ H. pylori IgG ELISA device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment relevant to the device's accuracy or effectiveness study.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, not on the detailed performance characteristics and study design of the device itself.
§ 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).