510(k) · Cleared
ClearedSensiTox C. difficile Toxin Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
First Light Diagnostics, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Jul 8, 2021 as substantially equivalent to K041003 (Meridian Bioscience, Inc., 2004) after a 569-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jul 8, 2021
- Review
- 569 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041003 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041003 Immunocard Toxins a & B, Model 712050Meridian Bioscience, Inc. · 2004 · Recalled
- This deviceK193490 SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041003 | Immunocard Toxins a & B, Model 712050 | Meridian Bioscience, Inc. | 2004 | 1 |
| 0 (this device) | K193490 | SensiTox C. difficile Toxin Test | First Light Diagnostics, Inc. | 2021 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K041003 | Immunocard Toxins a & B, Model 712050Summary page 4…vice Description Subject Device K041003 SensiTox C. difficile Toxin Test… | 2004 |
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 a recall.
- 2 other devices also cite its predicate K041003.
How does its category compare?
All LLH devicesLLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The SensiTox C. difficile Toxin Test is an immunofluorescence assay intended for the qualitative detection of Clostridioides difficile toxins A and/or B in human stool specimens. The test is intended as an aid in the diagnosis of C. difficile infection (CDI) in patients exhibiting symptoms of CDI. Negative results do not preclude toxigenic C. difficile infection. The SensiTox C. difficile Toxin Test should not be used as the sole basis for treatment or other management decisions. The test can only be used with the MultiPath platform.
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/K193490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193490: SensiTox C. difficile Toxin Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193490
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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