# K162969: LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

- Pathway: 510(k) (Special)
- Applicant: DiaSorin, Inc.
- Decided: Jan 6, 2017 after 74 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: 3 generations back to K915892 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040290: Diasorin Liaison CMV Igm/Igg, Diasorin S.P.A (2005) Summary page 5.

## Indications for use
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* 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. The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMYV IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® CMYV IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL. *(LIAISON® and LIAISON® XL).

Source page: https://510kreport.com/device/K162969
Methodology: https://510kreport.com/methodology