510(k) · Cleared
ClearedAccess Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC
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 May 23, 2008 as substantially equivalent to K951495 (Bio-Rad Laboratories, Inc., 1995) and 2 other predicates after a 53-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- May 23, 2008
- Review
- 53 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951495 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK951495 Access Toxo Igg Assay on the Access Immunoassay SystemBio-Rad Laboratories, Inc. · 1995
- 1 generation backK032162 Access Immunoassay System Toxo Igg AssayBeckman Coulter, Inc. · 2003
- This deviceK080869 Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QCBeckman Coulter, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK242022 Access Toxo IgGBeckman Coulter, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242022Access Toxo IgGBeckman Coulter, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951495 | Access Toxo Igg Assay on the Access Immunoassay System | Bio-Rad Laboratories, Inc. | 1995 | — |
| −1 | K032162 | Access Immunoassay System Toxo Igg Assay | Beckman Coulter, Inc. | 2003 | — |
| 0 (this device) | K080869 | Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC | Beckman Coulter, Inc. | 2008 | — |
| +1 | K242022 | Access Toxo IgG | Beckman Coulter, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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…icate Devices Access Toxo IgG Assay, Calibrators, QC (Part Numbers: 34450, 34455, 34459) Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Numbers: K951495, K032162 AxSYM Toxo IgG Antibody Assay Abbott Laboratories, Inc. 100 Abbott Park Road Abbott Park, IL 60064 510(k) Number: K9545… | 1995 |
| * | K032162 | Access Immunoassay System Toxo Igg AssaySummary page 1…ices Access Toxo IgG Assay, Calibrators, QC (Part Numbers: 34450, 34455, 34459) Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Numbers: K951495, K032162 AxSYM Toxo IgG Antibody Assay Abbott Laboratories, Inc. 100 Abbott Park Road Abbott Park, IL 60064 510(k) Number: K954575 Devic… | 2003 |
| * | K954575 | Axsym Toxo Igg Antibody AssaySummary page 1…rive Chaska, MN 55318 510(k) Numbers: K951495, K032162 AxSYM Toxo IgG Antibody Assay Abbott Laboratories, Inc. 100 Abbott Park Road Abbott Park, IL 60064 510(k) Number: K954575 Device Description The Access Toxo IgG Assay, Toxo IgG Calibrators, Toxo IgG QC, and the Access Immunoassay Analyzers (Access, A… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242022 | Access Toxo IgG | 2025 | 0 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K242022 (Beckman Coulter, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K951495.
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. 2008, this device’s year, is highlighted.
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 may be used to assess the immune status of pregnant women.
Note: In the United States, this product is not FDA cleared/approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens or infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080869 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080869: Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080869
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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