# K983841: Biotest Anti-Ebv Recombinant, Ebna Igg

- Pathway: 510(k) (Traditional)
- Applicant: Biotest Diagnostics Corp.
- Decided: Jun 9, 1999 after 222 days
- Product code: LSE (Epstein-Barr Virus, Other)
- Device class: 1
- Regulation: 21 CFR 866.3235
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946158 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946158: Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit, Incstar Corp. (1995) Summary page 2.

## Indications for use
The Biotest EBNA IgG ELISA is an enzyme immunoassay for the detection of IgG antibodies to the Epstein-Barr (EBV) EBNA-1 (Nuclear Antigen-1) in human serum or plasma. It is indicated for use, in conjunction with other clinical and patient data obtained in assays for other Epstein-Barr antigens such as Early Antigen IgG and IgM, in the serological diagnosis of EBV infection.

Source page: https://510kreport.com/device/K983841
Methodology: https://510kreport.com/methodology