(54 days)
This test system is designed for the manual or automated, qualitative detection of IgG antibodies to EBNA in human serum specimens. When used with other EBV serologies such as Heterophile, VCA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "The Aptus (automated) Application of the EBNA IgG ELISA Test System." This letter only states that the device is substantially equivalent to a legally marketed predicate device and grants permission to market it. It does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
Therefore, I cannot provide the specific answers to your questions based on the input text. The document is essentially a regulatory approval notice, not a scientific study report.
To answer your questions, I would need a different type of document, such as:
- A clinical study report
- A validation report
- The 510(k) summary (which might contain a brief overview of performance data but usually not in the level of detail you're asking for)
- The Instructions for Use (IFU) for the device, which often contains performance characteristics.
§ 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).