(91 days)
The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum. This test is intended to aid in the diagnosis of H. pylori infection in adult patients 18 years or older with clinical signs and symptoms of gastrointestinal disease. The QUANTA Lite™ H. pylori IgA should be performed and interpreted in conjunction with the QUANTA Lite™ H. pylori IgG for the detection of IgG antibodies to H.pylori .
The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum.
This document is a marketing approval letter for a medical device called QUANTA Lite™ H. pylori IgA ELISA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
To answer your request, I would need a study report or a different type of document that details the performance data and acceptance criteria for the QUANTA Lite™ H. pylori IgA ELISA device.
§ 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).