(60 days)
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the VISTA™ Antigen Salmonella H d. It grants market clearance for the device based on substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert qualifications, adjudication methods), or any mention of AI or standalone algorithm performance.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval, not a scientific study report.
§ 866.3550
Salmonella spp. serological reagents.(a)
Identification. Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifySalmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifySalmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genusSalmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever”), severe diarrhea, and cramps.(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.