# K973939: Immunowell Vca Igm Test

- Pathway: 510(k) (Traditional)
- Applicant: Genbio
- Decided: Aug 10, 1998 after 299 days
- Product code: LJN (Antibody Igm, If, Epstein-Barr Virus)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Epstein-Barr Viral Capsid Antigen IgM ELISA Kit, Gull Laboratories, Inc.: named in the summary without a submission number

## Indications for use
ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis {IM).

Source page: https://510kreport.com/device/K973939
Methodology: https://510kreport.com/methodology