510(k) · Cleared
ClearedImmunocard Stat! Ehec, Model 751630
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 Feb 14, 2007 as substantially equivalent to K953362 (Meridian Diagnostics, Inc., 1995) after a 168-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Feb 14, 2007
- Review
- 168 days
- Class
- Class I
- Product code
- GMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953362 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953362 Premier EhecMeridian Diagnostics, Inc. · 1995 · Recalled
- This deviceK062546 Immunocard Stat! Ehec, Model 751630Meridian Bioscience, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK121364 Shiga Toxin Quik ChekTechlab Inc., Corporate Research Center · 2012
- Descendant · 2 generations on · 0 of its ownK222829 Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK121411 Shiga Toxin ChekTechlab Inc., Corporate Research Center · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953362 | Premier Ehec | Meridian Diagnostics, Inc. | 1995 | 2 |
| 0 (this device) | K062546 | Immunocard Stat! Ehec, Model 751630 | Meridian Bioscience, Inc. | 2007 | — |
| +1 | K121364 | Shiga Toxin Quik Chek | Techlab Inc., Corporate Research Center | 2012 | — |
| +2 | K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | 2023 | — |
| +1 | K121411 | Shiga Toxin Chek | Techlab Inc., Corporate Research Center | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K953362 | Premier EhecSummary page 1…'s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coi (EHEC) infections. PREDICATE DEVICE: Premier EHEC (K953362) BACKGROUND: Among the E. Go/i human pathogens, Shiga toxin-producing strains of E. coi have gained in importance in recent years… | 1995 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2007, 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?
Immunoohromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coil in cultures derived from clinical stool specimens. ImmunoCard STATI EHEC is used in conjunction with the patients clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. co/i (EHEC) infections.
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/K062546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062546: Immunocard Stat! Ehec, Model 751630.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062546
Report an extraction error
Are you the manufacturer?
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