510(k) · Cleared
ClearedIncstar Toxoplasma Igm Capture Elisa Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incstar Corp. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on May 1, 1997 after a 253-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 1, 1997
- Review
- 253 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK963289 Incstar Toxoplasma Igm Capture Elisa AssayIncstar Corp. · 1997
- Descendant · cites it directly · 0 of its ownK052499 Diasorin Liaison Toxo Igg and Liaison Toxo Igm AssaysDiasorin S.P.A · 2006
Most influential descendants
Showing 1 of 1 · See all- K052499Diasorin Liaison Toxo Igg and Liaison Toxo Igm AssaysDiasorin S.P.A · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963289 | Incstar Toxoplasma Igm Capture Elisa Assay | Incstar Corp. | 1997 | — |
| +1 | K052499 | Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays | Diasorin S.P.A | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | — | BioWhittaker TOXOCAP-M ELISA test Named without a submission number |
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 |
|---|---|---|---|
| K052499 | Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays | 2006 | 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?
- Of its descendants, K052499 (Diasorin S.P.A, 2006) 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 | — |
What is it indicated for?
The INCSTAR Toxoplasma IgM Capture ELISA kit contains instructions and materials for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.
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/K963289 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963289: Incstar Toxoplasma Igm Capture Elisa Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963289
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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