510(k) · Cleared
ClearedVidas C. Dificile Toxin a & B (Cdab) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Jun 11, 2008 as substantially equivalent to K072138 (bioMerieux, Inc., 2007) after a 70-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Jun 11, 2008
- Review
- 70 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072138 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK072138 Vidas C. Difficile Toxin a&B (Cdab) Assay, Model: 30 118bioMerieux, Inc. · 2007
- This deviceK080931 Vidas C. Dificile Toxin a & B (Cdab) AssaybioMerieux, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072138 | Vidas C. Difficile Toxin a&B (Cdab) Assay, Model: 30 118 | bioMerieux, Inc. | 2007 | — |
| 0 (this device) | K080931 | Vidas C. Dificile Toxin a & B (Cdab) Assay | bioMerieux, Inc. | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K072138 | Vidas C. Difficile Toxin a&B (Cdab) Assay, Model: 30 118Summary page 1…Reagents, Clostridium Difficile Toxin C. Predicate Device Name Trade Name: VIDAS® C. difficile Toxin A & B(CDAB) assay [K072138] D. Device Description VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments… | 2007 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LLH devicesLLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Flurorescent Assay). The VIDAS C. difficile toxin A & toxin B (CDAB) assay is an aid for diagnosing Clostridium difficile associated disease (CDAD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080931: Vidas C. Dificile Toxin a & B (Cdab) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080931
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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