510(k) · Cleared
ClearedToxoplasma Igm Assay for the Bayer IMMUNO1 System (in Vitro Diagnostic System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Oct 22, 1997 after a 146-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 22, 1997
- Review
- 146 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 |
|---|---|---|---|
| * | — | Abbott IMx Toxoplasma IgM assay 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?
This in vitro diagnostic method is intended to qualitatively measure IgM antibodies to Toxoplasma gondii in human serum using the Bayer Immuno 1™ system. Measurements of anti-Toxoplasma IgM antibodies are presumptive for the diagnosis of recent Toxoplasma infection. Anti-Toxoplasma gondii IgM antibody measurements must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This method has not been cleared or approved by the FDA…
Read the full statement (110 words)
This in vitro diagnostic method is intended to qualitatively measure IgM antibodies to Toxoplasma gondii in human serum using the Bayer Immuno 1™ system. Measurements of anti-Toxoplasma IgM antibodies are presumptive for the diagnosis of recent Toxoplasma infection. Anti-Toxoplasma gondii IgM antibody measurements must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
This method has not been cleared or approved by the FDA for blood or plasma donor screening.
The use of the Bayer Immuno 1 Toxoplasma IgM method has not been validated for testing of cord blood or neonatal serum.
This method is intended for in vitro diagnostic use only on the Bayer Immuno 1 system.
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/K971989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971989: Toxoplasma Igm Assay for the Bayer IMMUNO1 System (in Vitro Diagnostic System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971989
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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