(41 days)
This lest system is an enzyme linked immunocorbent assay which provided a means for Use manual or automatod (Aptus), qualitative detection of IgG antibodies to EBV-EA in human serum. This test system is intended to be used as an ald in the diagricus's of infectious mononucloosis when used with other EBV serologies. The performarics characteristics have not been established to aid in the diagnosis of acute IM.
Not Found
The provided document is limited to a 510(k) clearance letter and an "Indications for Use" statement for the "Aptus (automated) Application for the EBV-EA IgG ELISA Test System." This type of document, particularly from 1998, typically does not contain the detailed study information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications that you are requesting.
The primary purpose of a 510(k) clearance is to establish substantial equivalence to a predicate device, not necessarily to provide a comprehensive breakdown of detailed performance studies in the way modern AI/ML device submissions might.
Therefore,Based on the provided document, the following information can be extracted, but many of your requested details are not available in this specific submission:
Acceptance Criteria and Reported Device Performance:
The document notes that the device is "substantially equivalent" to legally marketed predicate devices. This implies that its performance met the standards of those predicates. However, specific numerical acceptance criteria and the reported device performance against those criteria are not detailed in this document. The "Indications for Use" states: "The performance characteristics have not been established to aid in the diagnosis of acute IM." This is a limitation, not a performance metric for the intended use.
No Information Available for the following points in the provided document:
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).