510(k) · Cleared
ClearedAccess Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model 34470,34475,34479
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Jun 13, 2001 after a 238-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jun 13, 2001
- Review
- 238 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK003259 Access Toxo Igm II Reagents for Use on the Access Immunoassay…Beckman Coulter, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK242095 Access Toxo IgM IIBeckman Coulter, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK031506 Access Immunoassay System Toxo Igm II AssayBeckman Coulter, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003259 | Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2001 | — |
| +1 | K242095 | Access Toxo IgM II | Beckman Coulter, Inc. | 2024 | — |
| +1 | K031506 | Access Immunoassay System Toxo Igm II Assay | Beckman Coulter, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LGD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LGD device
- #1 K242022 Access Toxo IgGscore 9.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K242095 (Beckman Coulter, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LGD devicesLGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGD
Too few LGD 510(k)s in any year since 2007 to give a median.
Recalls per year · LGD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGD
89in 2025
MAUDE reports naming product code LGD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 4 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 1 | — | 0 | 91 |
| 2010 | 0 | — | 1 | 71 |
| 2011 | 2 | — | 0 | 115 |
| 2012 | 0 | — | 0 | 75 |
| 2013 | 2 | — | 0 | 35 |
| 2014 | 0 | — | 0 | 22 |
| 2015 | 1 | — | 0 | 121 |
| 2016 | 0 | — | 0 | 140 |
| 2017 | 1 | — | 0 | 173 |
| 2018 | 0 | — | 0 | 100 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 0 | — | 0 | 87 |
| 2021 | 0 | — | 1 | 38 |
| 2022 | 1 | — | 0 | 73 |
| 2023 | 0 | — | 0 | 118 |
| 2024 | 2 | — | 0 | 81 |
| 2025 | 1 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003259: Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model 34470,34475,34479.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003259
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026