(252 days)
The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV VCA IgM Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte® System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus.
The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV VCA IgM Test System is a microparticle-based immunoassay.
This is a tricky request as the provided text is a letter from the FDA regarding a 510(k) clearance, not a study report. It states that the device is substantially equivalent to a legally marketed predicate device, but it does not contain the details of any specific study that would directly provide acceptance criteria and reported device performance in the format requested.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the approval is based on comparison to existing devices, not necessarily a new, standalone performance study with defined acceptance criteria provided in this document.
Therefore, I cannot directly extract the specific information requested about acceptance criteria and a study proving device performance from the provided text. The document is an approval letter, not a study report.
If you had a study report for the AtheNA Multi-Lyte® EBV VCA IgM Test System, I would be able to populate the requested table and answer the questions.
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).