# K031506: Access Immunoassay System Toxo Igm II Assay

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 2, 2003 after 19 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 K003259 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003259: Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model 34470,34475,34479, Beckman Coulter, Inc. (2001) Summary page 1.

## Indications for use
The Access Toxo IgM II assay is a paramagnetic-particle,chemiluminescent immunoassay for the qualitative determination of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma, using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.

Source page: https://510kreport.com/device/K031506
Methodology: https://510kreport.com/methodology