(208 days)
This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces.
It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.
This document is an FDA 510(k) clearance letter for the Giardia Antigen Detection Microwell ELISA Assay. It does not contain information about acceptance criteria, device performance, sample sizes for testing/training, ground truth establishment, or human reader effectiveness studies.
The provided text is purely an FDA clearance letter and an "Indication For Use" statement. It does not include a study description with the requested details. Therefore, I cannot extract the information to complete the table or answer the questions.
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.