# K131441: Liaison Toxo Igm II, Liaison Control Toxo Igm II

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Aug 9, 2013 after 81 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: 1 generation back to K001707 (2000). 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)
- K001707: Diamedix IS-Toxoplasma Igm Capture Test System, Diamedix Corp. (2000) Summary page 3.

## Indications for use
The DiaSorin LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON Toxo IgM II is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended, that the LIAISON Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. The DiaSorin LIAISON® Control Toxo IgM II is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® Toxo IgM II assay on the LIAISON® XL Analyzer.

Source page: https://510kreport.com/device/K131441
Methodology: https://510kreport.com/methodology