# K915892: CMV Igg Elisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Gull Laboratories, Inc.
- Decided: Feb 14, 1992 after 52 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955361: Incstar Cytomegalovirus Igg Elisa Assay (1996), 4 descendants of its own
- K040290: Diasorin Liaison CMV Igm/Igg (2005), 3 descendants of its own
- K162969: LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (2017), 0 descendants of its own
- K161526: LIAISON CMV IgM Serum Control Set (2016), 0 descendants of its own
- K161522: LIAISON EBV IgM Serum Control Set (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K915892
Methodology: https://510kreport.com/methodology