510(k) · Cleared
ClearedShiga Toxin Quik 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 148-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Oct 2, 2012
- Review
- 148 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. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK953362 Premier EhecMeridian Diagnostics, Inc. · 1995 · Recalled
- 1 generation backK062546 Immunocard Stat! Ehec, Model 751630Meridian Bioscience, Inc. · 2007
- This deviceK121364 Shiga Toxin Quik ChekTechlab Inc., Corporate Research Center · 2012
- Descendant · cites it directly · 0 of its ownK222829 Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222829Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023 · cites it directly0descendants
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) | K121364 | Shiga Toxin Quik Chek | Techlab Inc., Corporate Research Center | 2012 | — |
| +1 | K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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…Detection of Shiga toxins 1 and 2 from direct fecal samples, Premnierm" EHEC K953362 broth cultures of fecal Microwell ELISA Persons suspected of specimens, individua… | 1995 |
| * | K062546 | Immunocard Stat! Ehec, Model 751630Summary page 3…sweeps of agar plates ImuoadSa!Detection of Shiga Immuno- Persons suspected of Imunar Sat K062546 toxins 1 and 2 in chromatographic having STEC infection EHCcultures derived from… | 2007 |
| * | K980507 | Prospect Shiga Toxin Microplate AssaySummary page 4…Page 3 of 9 Simitarities immunoCard STAT! ProSpecT Shiga tem | SHIGA TOXIN.QUIK EHEC PREMIER EHEC | 1oxin . coli(STEC) CHEK K062546 K953362 K980507 -~ . - . o . Qualitative Detection Intended Qualitative Detection of | Qualitative Detection of | Qualitative Detection of of Shi… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222829 | Curian® Shiga Toxin | 2023 | 0 |
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.
- Of its descendants, K222829 (Meridian Bioscience, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 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 QUIK CHEK test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. 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 coli (STEC). It may be used with 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121364: Shiga Toxin Quik Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121364
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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