# K162678: Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 23, 2017 after 270 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 4.

## Indications for use
Elecsys Toxo IgM Immunoassay The Elecsys Toxo IgM immunoassay is for the in vitro qualitative detection of IgM antibodies to Toxoplasma gondii in human serum and plasma. This assay may be used as an aid in the diagnosis of an acute or recent Toxoplasma gondii infection in suspected patients and pregnant women. Patient testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immuno-assay analyzers. This assay has not been cleared by the FDA for blood/plasma donor screening. PreciControl Toxo IgM PreciControl Toxo IgM is used for quality control of the Elecsys Toxo IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K162678
Methodology: https://510kreport.com/methodology