510(k) · Cleared
ClearedIncstar Toxoplasma Igg Alisa Assay (Cat.#7565)
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 Dec 16, 1996 as substantially equivalent to K915891 (Gull Laboratories, Inc., 1992) after a 117-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Dec 16, 1996
- Review
- 117 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915891 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915891 Toxo Igg Elisa Test (Modified)Gull Laboratories, Inc. · 1992
- This deviceK963296 Incstar Toxoplasma Igg Alisa Assay (Cat.#7565)Incstar Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915891 | Toxo Igg Elisa Test (Modified) | Gull Laboratories, Inc. | 1992 | — |
| 0 (this device) | K963296 | Incstar Toxoplasma Igg Alisa Assay (Cat.#7565) | Incstar Corp. | 1996 | — |
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 |
|---|---|---|---|
| * | K915891 | Toxo Igg Elisa Test (Modified)Summary page 2…d to the solid phase. SAFETY AND EFFECTIVENESS: The INCSTAR Toxoplasma IgG ELISA Kit is substantially equivalent (SE) to the Gull Toxoplasma IgG ELISA test, 510(k) No. K915891, which has been cleared by the FDA and is currently in U.S. commercial distribution. In clinical performance studies, 300 serum… | 1992 |
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.
What does this lineage say?
- Its one ancestor has no 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 INCSTAR Toxoplasma IgG ELISA kit contains instructions and materials for qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgG ELISA is of value in the determination of immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and…
Read the full statement (100 words)
The INCSTAR Toxoplasma IgG ELISA kit contains instructions and materials for qualitative and/or semi-quantitative detection of IgG antibodies to Toxoplasma gondii in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgG ELISA is of value in the determination of immunological response to infection with Toxoplasma gondii. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary or reactivated infection with Toxoplasma gondii. 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/K963296 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963296: Incstar Toxoplasma Igg Alisa Assay (Cat.#7565).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963296
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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