510(k) · Cleared
ClearedDuopath Verotoxins Glisa Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emd Chemicals, Inc. · GNA Antisera, All Types, Escherichia Coli
Cleared on Jan 23, 2004 after a 268-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 23, 2004
- Review
- 268 days
- Class
- Class I
- Product code
- GNA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GNA? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 GNA devicesGNA Antisera, All Types, Escherichia Coli: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GNA
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GNA
Too few GNA 510(k)s in any year since 2007 to give a median.
Recalls per year · GNA
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNA
No MAUDE report names GNA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 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 | — | 1 | 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?
The Duopath® Verotoxins GLISA test is a rapid test for the qualitative identification of Verotoxins I and II (Shiga-like toxins) produced by E. coli isolated in cultures derived from clinical specimens. The identification aids in the diagnosis of diseases caused by enterohemorrhagic E. coli infections.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031367: Duopath Verotoxins Glisa Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031367
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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