510(k) · Cleared
ClearedAccess Immunoassay System Toxo Igg Assay
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 Aug 8, 2003 as substantially equivalent to K951495 (Bio-Rad Laboratories, Inc., 1995) after a 24-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951495 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951495 Access Toxo Igg Assay on the Access Immunoassay SystemBio-Rad Laboratories, Inc. · 1995
- This deviceK032162 Access Immunoassay System Toxo Igg AssayBeckman Coulter, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK080869 Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QCBeckman Coulter, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK242022 Access Toxo IgGBeckman Coulter, Inc. · 2025
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 |
|---|---|---|---|---|---|
| −1 | K951495 | Access Toxo Igg Assay on the Access Immunoassay System | Bio-Rad Laboratories, Inc. | 1995 | — |
| 0 (this device) | K032162 | Access Immunoassay System Toxo Igg Assay | Beckman Coulter, Inc. | 2003 | — |
| +1 | K080869 | Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC | Beckman Coulter, Inc. | 2008 | — |
| +2 | K242022 | Access Toxo IgG | Beckman Coulter, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951495 | Access Toxo Igg Assay on the Access Immunoassay SystemSummary page 1…ss Class I1 Legally Marketed (Unmodified) Access Toxo IgG Assay for use on the Access Immunoassay Device Systems (K951495, cleared 12/20/95) Device Description The Access Toxo IgG reagents consist of reagent packs, calibrators, QC, substrate and… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080869 | Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC | 2008 | 1 |
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?
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 | — |
What is it indicated for?
The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay
for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii
in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay
aids in the diagnosis of Toxoplasma gondii infection and in the determination of
protective levels of antibodies in pregnant women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032162 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032162: Access Immunoassay System Toxo Igg Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032162
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026