# K073501: Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 9, 2008 after 179 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 2.

## Indications for use
The Elecsys Toxo IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to Toxoplasma gondi in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay is intended for use as an aid in the assessment of immune status and as an aid in the diagnosis of primary infection. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl Toxo IgG is used for quality control of the Elecsys Toxo IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K073501
Methodology: https://510kreport.com/methodology