# K032162: Access Immunoassay System Toxo Igg Assay

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 8, 2003 after 24 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 K951495 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951495: Access Toxo Igg Assay on the Access Immunoassay System, Bio-Rad Laboratories, Inc. (1995) Summary page 1.

## Most influential descendants
- K080869: Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC (2008), 1 descendant of its own
- K242022: Access Toxo IgG (2025), 0 descendants of its own

## Indications for use
The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and in the determination of protective levels of antibodies in pregnant women.

Source page: https://510kreport.com/device/K032162
Methodology: https://510kreport.com/methodology