(60 days)
The VZV IgG ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgG-class antibody to VZV in human serum. The test is intended to be used to aid in the determiation of immune status, and/or aid in the diagnosos of VZV infections, and is for in vitro diagnostic use.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Aptus (automated) Application for the VZV IgG ELISA Test System". This document grants clearance based on substantial equivalence to a predicate device and describes the intended use of the device, but it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance, not the specifics of the clinical study that would have supported the 510(k) submission.
To answer your questions, I would need access to the actual 510(k) submission document or a summary of the clinical study, which are not provided in the given text.
§ 866.3900 Varicella-zoster virus serological reagents.
(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).