510(k) · Cleared
ClearedCurian® Shiga Toxin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · GMZ Antigens, All Types, Escherichia Coli
Cleared on Apr 17, 2023 as substantially equivalent to K121364 (Techlab Inc., Corporate Research Center, 2012) after a 210-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 17, 2023
- Review
- 210 days
- Class
- Class I
- Product code
- GMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953362 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK953362 Premier EhecMeridian Diagnostics, Inc. · 1995 · Recalled
- 2 generations backK062546 Immunocard Stat! Ehec, Model 751630Meridian Bioscience, Inc. · 2007
- 1 generation backK121364 Shiga Toxin Quik ChekTechlab Inc., Corporate Research Center · 2012
- This deviceK222829 Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953362 | Premier Ehec | Meridian Diagnostics, Inc. | 1995 | 2 |
| −2 | K062546 | Immunocard Stat! Ehec, Model 751630 | Meridian Bioscience, Inc. | 2007 | — |
| −1 | K121364 | Shiga Toxin Quik Chek | Techlab Inc., Corporate Research Center | 2012 | — |
| 0 (this device) | K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 GMZ? 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 |
|---|---|---|---|
| * | K121364 | Shiga Toxin Quik ChekSummary page 5…0 mL. J. Substantial Equivalence Information: 1. Predicate device name(s): SHIGA TOXIN QUIK CHEK 2. Predicate 510(k) number: K121364 3. Comparison with predicate: PRE… | 2012 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All GMZ devicesGMZ Antigens, All Types, Escherichia Coli: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GMZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GMZ
Too few GMZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GMZ
No recall names GMZ since 2007.
Adverse event reports per year · GMZ
1in 2017
MAUDE reports naming product code GMZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient’s clinical symptoms and history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222829: Curian® Shiga Toxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222829
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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