(60 days)
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
Not Found
The provided text is a 510(k) premarket notification approval letter for the VISTA™ Antigen Salmonella O Group D device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The letter primarily covers:
- The FDA's determination of substantial equivalence for the device.
- Regulatory classifications and general controls applicable to the device.
- Contact information for further regulatory guidance.
- An enclosure indicating the device's indications for use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."
Therefore, I cannot provide the requested information based on the given document.
§ 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.