(149 days)
The Zeus Scientific, Inc. Helicobacter pylori IgG ELISA test System is intended for the qualitative detection of IgG antibody in symptomatic adult serum. It may or may not be indicated as an aid in the determination of serological status.
Not Found
I am sorry, but based on the provided text, I cannot extract the specific acceptance criteria, study details, or performance metrics within the document. The text is a formal letter from the FDA regarding a 510(k) clearance for the "Helicobacter pylori IgG ELISA Test System," confirming its substantial equivalence to previously marketed devices.
This type of letter focuses on the regulatory approval and does not typically include the detailed technical performance data of the device, the study design, or the specific criteria met for that approval. These details would usually be found within the 510(k) submission document itself, which is not provided here.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, or training set details.
§ 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).