(60 days)
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
Not Found
This document is an FDA 510(k) clearance letter for the VISTA™ Antigen Brucella abortus device. It does not contain details about acceptance criteria, study design, or performance metrics beyond the statement that the device is "substantially equivalent" to predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert qualifications, or ground truth methods from this document. The letter primarily confirms regulatory clearance based on substantial equivalence to existing devices, without detailing the specific performance studies that led to this determination.
§ 866.3085
Brucella spp. serological reagents.(a)
Identification. Brucella spp. serological reagents are devices that consist of antigens and antisera used for serological identification ofBrucella spp. from cultured isolates derived from clinical specimens or to identify antibodies toBrucella spp. in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyBrucella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of brucellosis (e.g., undulant fever, Malta fever) caused by bacteria belonging to the genusBrucella and provides epidemiological information on diseases caused by these microorganisms.(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.