510(k) · Cleared
ClearedToxogen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GMM Antigens, Iha, Toxoplasma Gondii
Cleared on Aug 6, 1998 as substantially equivalent to K913467 (Biokit USA, Inc., 1993) after a 121-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 6, 1998
- Review
- 121 days
- Class
- Class II
- Product code
- GMM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913467 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK913467 ToxogenBiokit USA, Inc. · 1993
- This deviceK981263 ToxogenInstrumentation Laboratory CO · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913467 | Toxogen | Biokit USA, Inc. | 1993 | — |
| 0 (this device) | K981263 | Toxogen | Instrumentation Laboratory CO | 1998 | — |
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 GMM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K913467 | ToxogenSummary page 1…red: April 6, 1997 Name of the device: Toxogen Classification name(s): 866.3780 Toxoplasma gondii serological reagents Class 11 Identification of predicate device(s): K913467/D Toxogen Description of the device/intended use(s): Toxogen is an in vitro diagnostic, rapid latex particle agglutination test… | 1993 |
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 GMM devicesGMM Antigens, Iha, Toxoplasma Gondii: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GMM
FDA has decided no GMM device since 2007.
Median 510(k) review, days · GMM
Too few GMM 510(k)s in any year since 2007 to give a median.
Recalls per year · GMM
No recall names GMM since 2007.
Adverse event reports per year · GMM
No MAUDE report names GMM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis.
This assay is not FDA cleared for use in blood or plasma donor screening.
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/K981263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981263: Toxogen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981263
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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