# K040290: Diasorin Liaison CMV Igm/Igg

- Pathway: 510(k) (Traditional)
- Applicant: Diasorin S.P.A
- Decided: Jun 1, 2005 after 481 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
Longest line of descent: 2 generations back to K915892 (1992). 3 ancestors in all.
3 later devices descend from it; 3 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)
- K955361: Incstar Cytomegalovirus Igg Elisa Assay, Incstar Corp. (1996) Summary page 1.
- K001767: Diamedix IS-CMV Igm Capture Test System, Diamedix Corp. (2000) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The LIAISON® CMV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the diagnosis of acute CMV infection. The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.

Source page: https://510kreport.com/device/K040290
Methodology: https://510kreport.com/methodology