(139 days)
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- For in vitro diagnostic use only.
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- For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
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- Individual specimens may be used for the determination of immune status.
- Paired (acute / convalescent) sera, may be used to demonstrate seroconversion 4. or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.
Not Found
I am sorry, but based on the text provided, I cannot answer the request as there is no information about the acceptance criteria and study that proves the device meets the acceptance criteria. The text consists of a letter from the FDA regarding the 510(k) premarket notification for the SeraQuest VAV IgG device and its indications for use. It does not contain any details about performance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
§ 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).