# K080869: Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 23, 2008 after 53 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 K951495 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K032162: Access Immunoassay System Toxo Igg Assay, Beckman Coulter, Inc. (2003) Summary page 1.
- K954575: Axsym Toxo Igg Antibody Assay, Abbott Laboratories (1996) Summary page 1.

## Most influential descendants
- 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 may be used to assess the immune status of pregnant women. Note: In the United States, this product is not FDA cleared/approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens or infants.

Source page: https://510kreport.com/device/K080869
Methodology: https://510kreport.com/methodology