510(k) · Cleared
ClearedShiga Toxin Chek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab Inc., Corporate Research Center · GMZ Antigens, All Types, Escherichia Coli
Cleared on Oct 2, 2012 as substantially equivalent to K953362 (Meridian Diagnostics, Inc., 1995) and 2 other predicates after a 144-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Oct 2, 2012
- Review
- 144 days
- Class
- Class I
- Product code
- GMZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953362 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953362 | Premier Ehec | Meridian Diagnostics, Inc. | 1995 | 2 |
| −1 | K062546 | Immunocard Stat! Ehec, Model 751630 | Meridian Bioscience, Inc. | 2007 | — |
| 0 (this device) | K121411 | Shiga Toxin Chek | Techlab Inc., Corporate Research Center | 2012 | — |
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.
Top candidate predicates for a new GMZ device
- #1 K222829 Curian® Shiga Toxinscore 5.8 · 3 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K953362 | Premier EhecSummary page 3…tion of Shiga toxins 1and 2 from direct fecal samples, PremierTm EHEC K953362 broth cultures of fecal Microwell ELISA Persons suspected of specimens, in… | 1995 |
| * | K062546 | Immunocard Stat! Ehec, Model 751630Summary page 3…Detection of Shiga Imn-Prosssetdo Immunoard Stati toxins 1 and 2 in Imn-Prosssetdo EHEC K062546 cultures derived from chromatographic having STEC infection clinical sto… | 2007 |
| * | K980507 | Prospect Shiga Toxin Microplate AssaySummary page 3…Persons suspected of PropecT Shiga toxins (Stxl and Stx2) having STEC infection Toxin E. co/i (EHEC) K980507 in aqueous extracts of Microplate ELISA MirpaeELISA fecal specimens and… | 1998 |
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 17 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 3 other devices also cite its predicate K953362.
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. 2012, 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 SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coi (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121411: Shiga Toxin Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121411
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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