# K073390: Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-Controls

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Nov 21, 2008 after 354 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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 K003412 (2001). 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)
- K003412: Advia Centaur Rubella Igg Assay, Bayer Corp. (2001) Summary page 1.

## Indications for use
The LIAISON® Rubella IgG uses chemiluminescence immunoussay (CLIA) technology on the LlAlSON® Analyzcr for the qualitative determination of IgG antibodies to rubella virus in human serum specimens. It is intended for use as an aid in the determination of immune status to rubella in individuals including pregnant women. The performance of this device has not been established for cord blood, neonatal samples, or for any matrices other than human serum. Likcwise, performance has not been established for population(s) of immunocompromised or immunosuppressed individuals. The LIAISON® Rubella IgG Tri-Control kit is intended for use as assayed quality control samples to monitor the performance of the LIATSON® Rubella 1gG assay.

Source page: https://510kreport.com/device/K073390
Methodology: https://510kreport.com/methodology