# K132234: Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Aug 28, 2013 after 41 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- 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 K010668 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981498: IS-Toxoplasma Igg Test System, Diamedix Corp. (1998) Summary page 1.
- K122397: Liaison Rubella Igm, Liaison Control Rubella Igm, DiaSorin, Inc. (2012) Summary page 1.

## Most influential descendants
- K161139: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (2016), 1 descendant of its own
- K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (2018), 0 descendants of its own

## Indications for use
The LIAISON® Toxo IgG 11assay uses chemi luminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific lgG antibodies to Toxoplasma gondli in human serum. The results of this assay can be used as an aid in the assessment of the patient's serological status to infection with Toxoplasma gondil and in the determination of immune status of individuals including pregnant women. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. U.S. Federal Law restricts this device to sale by or on the order of a physician. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. The LIAISON® Control Toxo IgG 11(negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG 11assay on the LIAISON® XL Analyzer.

Source page: https://510kreport.com/device/K132234
Methodology: https://510kreport.com/methodology