# K233932: Alinity i Toxo IgM

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 30, 2024 after 260 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 K923166 (1993). 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)
- K923166: Vidas Toxoplasma Gondii Igm Asssay, Biomerieux Vitek, Inc. (1993) Summary page 6.

## Indications for use
The Alinity i Toxo IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system. The Alinity i Toxo IgM assay is to be used as an aid in the diagnosis of acute or recent Toxoplasma gondii infection in suspected individuals including women of child-bearing age. It is recommended that the assay be performed in conjunction with a Toxoplasma gondii IgG assay. The Alinity i Toxo IgM assay has not been cleared for use in screening blood, plasma, or tissue donors.

Source page: https://510kreport.com/device/K233932
Methodology: https://510kreport.com/methodology