510(k) · Cleared
ClearedTox a/B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Jul 22, 1997 after a 113-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jul 22, 1997
- Review
- 113 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK971182 Tox a/B TestTechlab, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK033479 Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK030404 C. Difficile Tox a/B IITechlab, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004 · cites it directly2descendants
- K030404C. Difficile Tox a/B IITechlab, Inc. · 2003 · cites it directly2descendants
- K050891Tox a/B Quick ChekTechlab, Inc. · 2005 · 2 generations on1descendant
- K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971182 | Tox a/B Test | Techlab, Inc. | 1997 | — |
| +1 | K033479 | Prospect Clostridium Difficile Toxin a/B Microplate Assay | Remel, Inc. | 2004 | — |
| +1 | K030404 | C. Difficile Tox a/B II | Techlab, Inc. | 2003 | — |
| +2 | K050891 | Tox a/B Quick Chek | Techlab, Inc. | 2005 | — |
| +2 | K082499 | C. Diff Quik Chek Complete | Techlab, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K033479 (Remel, Inc., 2004) has gone furthest, with 2 descendants 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?
The TOX A/B TEST is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.
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/K971182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971182: Tox a/B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971182
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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