(60 days)
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
Not Found
I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for the VISTA™ Antigen Salmonella O Group C device, indicating that the device has been found substantially equivalent to a predicate device.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study that proves the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on the type of ground truth used or the sample size and ground truth establishment for a training set.
The document primarily focuses on the regulatory clearance of the device for its indicated use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."
§ 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.