# K210596: ARCHITECT Toxo IgG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 19, 2022 after 444 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 K993319 (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)
- K993319: Vidas Toxo Igg II (TXG) Assay Model 30 210, bioMerieux, Inc. (2000) Summary page 5.

## Indications for use
The ARCHITECT Toxo IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to Toxoplasma gondii in human serum and plasma on the ARCHITECT i System. The ARCHITECT Toxo IgG assay is to be used as an aid in the detection of immune status to Toxoplasma gondii in individuals, including women of child-bearing age, and as an aid in the diagnosis of Toxoplasma gondii infection. Not intended for use in screening blood, plasma, or tissue donors.

Source page: https://510kreport.com/device/K210596
Methodology: https://510kreport.com/methodology