# K012183: Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Dec 27, 2001 after 168 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 K922737 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922737: Vidas Toxo IG6 Assay (TX6), Biomerieux Vitek, Inc. (1993) Summary page 1.

## Most influential descendants
- K102681: Advia Centaur Toxoplasma Igg (Toxo G) (2011), 0 descendants of its own

## Indications for use
The ADVIA Centaur Toxoplasma IgG assay is an IgG antibody capture microparticle direct chemiluminometric immunoassay for the quantitative or qualitative detection of IgG antibodies to the Toxoplasma gondii parasite in human serum or plasma (EDTA, heparin) using the ADVIA Centaur System. The measurement of Toxoplasma IgG may be used to aid in the assessment of a patient's serological response from individuals including women of childbearing age. This assay may also be utilized with an IgM Toxoplasma result to determine recent serological response to Toxoplasma.. Testing should not be performed as a screening procedure for the general population. This assay has not been cleared or approved by the FDA for the screening of blood or plasma donors.

Source page: https://510kreport.com/device/K012183
Methodology: https://510kreport.com/methodology