# K974456: Cmvgen

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 1, 1998 after 157 days
- Product code: LJO (Antigen, Iha, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- 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 K841520 (1984). 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)
- K841520: CMV Latex Agglutination Test Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1984) Summary page 1.

## Indications for use
CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma to determine prior exposure to cytomegalovirus. This assay has not been FDA cleared for use in screening blood or plasma donors.

Source page: https://510kreport.com/device/K974456
Methodology: https://510kreport.com/methodology