(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 letter from the FDA to Lee Laboratories regarding the VISTA™ Antigen Brucella melitensis device. This document primarily focuses on regulatory approval and does not contain the detailed study information needed to answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. However, it does not provide the specific performance data or the study design details that would be found in a clinical or validation study report.
Therefore, most of the information requested cannot be extracted from this document.
Here's what can be stated based on the provided text:
- Device Name: VISTA™ Antigen Brucella melitensis
- Indications For Use: Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum.
All other points (acceptance criteria, reported device performance, sample sizes, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not present in this regulatory approval letter.
§ 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.