# K003259: Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model 34470,34475,34479

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 13, 2001 after 238 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.
2 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K242095: Access Toxo IgM II (2024), 0 descendants of its own
- K031506: Access Immunoassay System Toxo Igm II Assay (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K003259
Methodology: https://510kreport.com/methodology