# K983842: Biotest Anti-Ebv Recombinant, EA Igm

- 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 K822734 (1982). 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)
- K822734: Ebv Igm Test, Gull Laboratories, Inc. (1982) Summary page 2.

## Indications for use
The Biotest EA IgM is an enzyme immunoassay for the detection of IgM antibodies to the Epstein-Barr Virus (EBV-EA (Early Antigens) p54/p138) 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 EBNA IgG and Early Antigen IgG, in the serological diagnosis of EBV infection.

Source page: https://510kreport.com/device/K983842
Methodology: https://510kreport.com/methodology