# K102681: Advia Centaur Toxoplasma Igg (Toxo G)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 4, 2011 after 229 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: 2 generations back to K922737 (1993). 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)
- K012183: Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay, Bayer Diagnostics Corp. (2001) Summary page 1.

## Indications for use
The AD VIA Centaur Toxoplasma lgG assay is an IgG antibody capture microparticle direct in vitro diagnostic immunoassay intended for the quantitative and qualitative detection of lgG antibodies to the Toxoplasma gondil parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur systems. The measurement of Toxoplasma lgG may be used to aid in the assessment of a patient's immunological response from individuals including women of childbearing age. This assay may be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.

Source page: https://510kreport.com/device/K102681
Methodology: https://510kreport.com/methodology