# K161526: LIAISON CMV IgM Serum Control Set

- Pathway: 510(k) (Special)
- Applicant: DiaSorin, Inc.
- Decided: Jun 30, 2016 after 28 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 4.

## Indications for use
The LIAISON® CMV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgM assay on the LIAISON® Analyzer family.

Source page: https://510kreport.com/device/K161526
Methodology: https://510kreport.com/methodology