# K951495: Access Toxo Igg Assay on the Access Immunoassay System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Dec 20, 1995 after 264 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032162: Access Immunoassay System Toxo Igg Assay (2003), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K951495
Methodology: https://510kreport.com/methodology