# LGD: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

- Device class: 2; regulation: 21 CFR 866.3780; FDA's rule: 510(k) required
- FDA decisions: 106
- 510(k) review time 2021–2025: median 260 days (middle half 217–306)
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2008: 2
- 2009: 1
- 2011: 2
- 2013: 2
- 2015: 1
- 2017: 1
- 2022: 1
- 2024: 2
- 2025: 1

## Most-cited predicates
- K923166: Vidas Toxoplasma Gondii Igm Asssay (1993), cited by 6
- K993319: Vidas Toxo Igg II (TXG) Assay Model 30 210 (2000), cited by 3
- K981498: IS-Toxoplasma Igg Test System (1998), cited by 2
- K003259: Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model 34470,34475,34479 (2001), cited by 2
- K951495: Access Toxo Igg Assay on the Access Immunoassay System (1995), cited by 2
- K913787: Toxoplasma Igm Elisa Test System (1991), cited by 1
- K954575: Axsym Toxo Igg Antibody Assay (1996), cited by 1
- K922737: Vidas Toxo IG6 Assay (TX6) (1993), cited by 1
- K891781: Toxo Elisa Test System (1989), cited by 1
- K963289: Incstar Toxoplasma Igm Capture Elisa Assay (1997), cited by 1

Source page: https://510kreport.com/product-code/LGD
Data by year (CSV): https://510kreport.com/product-code/LGD.csv