# K052499: Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays

- Pathway: 510(k) (Traditional)
- Applicant: Diasorin S.P.A
- Decided: Feb 8, 2006 after 148 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 K963289 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963289: Incstar Toxoplasma Igm Capture Elisa Assay, Incstar Corp. (1997) Summary page 1.
- K981498: IS-Toxoplasma Igg Test System, Diamedix Corp. (1998) Summary page 5.

## Indications for use
The LIAISON® Toxo IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the the qualitative determination of specific IgG antibodies to Toxoplasma gondii 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 gondii and in the determination of immune status of individuals including pregnant women. This assay has not been clearedlapproved by the F.D.A for blood/plasma donor screening. The LIAISON® Toxo IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON® Toxo IgM can be used as an aid in the presumptive diagnosis of acute or recent t Toxoplasma gondii infection. It is recommended tha ;he LIAISON® Toxo IgM assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the F.D.A for blood/plasma donor screening.

Source page: https://510kreport.com/device/K052499
Methodology: https://510kreport.com/methodology