510(k) · Cleared
Recalled · 2006Immunocard Toxins a & B, Model 712050
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Aug 20, 2004 after a 123-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 20, 2004
- Review
- 123 days
- Class
- Class I
- Product code
- LLH
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK041003 Immunocard Toxins a & B, Model 712050Meridian Bioscience, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK193490 SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009
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 |
|---|---|---|---|---|---|
| 0 (this device) | K041003 | Immunocard Toxins a & B, Model 712050 | Meridian Bioscience, Inc. | 2004 | — |
| +1 | K050891 | Tox a/B Quick Chek | Techlab, Inc. | 2005 | — |
| +1 | K193490 | SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. | 2021 | — |
| +1 | K082499 | C. Diff Quik Chek Complete | Techlab, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2021 | 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 LLH? 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 LLH device
- #1 K193490 SensiTox C. difficile Toxin Testscore 1.6 · 1 generation · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Premier Toxins A & B Named without a submission number | |
| * | — | ImmunoCard Toxin A Named without a submission number | |
| * | — | C. difficile ToxA/B II Named without a submission number | |
| * | — | Oxoid Clearview C. difficile Toxin A Named without a submission number | |
| * | — | ColorPAC Toxin A Named without a submission number |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Jun 2, 2006 | Not classified | Z-1203-06 | Other | The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050891 (Techlab, Inc., 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLH devicesLLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LLH
84in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLH
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLH
1in 2025
MAUDE reports naming product code LLH, 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 | 2 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 0 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 0 |
| 2013 | 0 | — | 2 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ImmunoCard Toxins A & B is an in vitro diagnostic qualitative enzyme immunoassay to detect the presence of Clostridium difficile toxins A and B in human stool. The assay is used as an aid in the diagnosis of C. difficile-associated disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041003 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041003: Immunocard Toxins a & B, Model 712050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041003
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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