510(k) · Cleared
Recalled · Class II · 2016Premier Ehec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Diagnostics, Inc. · GNA Antisera, All Types, Escherichia Coli
Cleared on Nov 14, 1995 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 14, 1995
- Review
- 120 days
- Class
- Class I
- Product code
- GNA
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK953362 Premier EhecMeridian Diagnostics, Inc. · 1995
- Descendant · cites it directly · 3 of its ownK062546 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 · cites it directly · 1 of its ownK061889 Biostar Oia ShigatoxInverness Medical-Biostar, Inc. · 2006 · Recalled
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062546Immunocard Stat! Ehec, Model 751630Meridian Bioscience, Inc. · 2007 · cites it directly3descendants
- K121364Shiga Toxin Quik ChekTechlab Inc., Corporate Research Center · 2012 · cites it directly1descendant
- K061889Biostar Oia ShigatoxInverness Medical-Biostar, Inc. · 2006 · cites it directly1descendant
- K222829Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023 · 2 generations on0descendants
- K121411Shiga Toxin ChekTechlab Inc., Corporate Research Center · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953362 | Premier Ehec | Meridian Diagnostics, Inc. | 1995 | — |
| +1 | K062546 | Immunocard Stat! Ehec, Model 751630 | Meridian Bioscience, Inc. | 2007 | — |
| +1 | K121364 | Shiga Toxin Quik Chek | Techlab Inc., Corporate Research Center | 2012 | — |
| +1 | K061889 | Biostar Oia Shigatox | Inverness Medical-Biostar, Inc. | 2006 | 1 |
| +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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2012 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2016 | Class II | Z-1033-2017 | Under Investigation by firm | Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. |
| Oct 10, 2011 | Not classified | Z-0203-2012 | Nonconforming Material/Component | Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062546 (Meridian Bioscience, Inc., 2007) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K953362 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953362: Premier Ehec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953362
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026