510(k) · Cleared
ClearedAccess Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Sep 17, 1998 after a 371-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 17, 1998
- Review
- 371 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Platelia® Toxo IgM Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
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 IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM 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 an anti-Toxoplasma gondii 1gG antibcdy assay.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973448: Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973448
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026