510(k) · Cleared
Recalled · 2003Premier Toxins a&B, Model 616096
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Diagnostics, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Dec 10, 1999 as substantially equivalent to K911958 (Cambridge Biotech Corp., 1991) after a 23-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 10, 1999
- Review
- 23 days
- Class
- Class I
- Product code
- LLH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911958 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK911958 Cytoclone a & B EiaCambridge Biotech Corp. · 1991
- This deviceK993914 Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK033479 Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
- 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 |
|---|---|---|---|---|---|
| −1 | K911958 | Cytoclone a & B Eia | Cambridge Biotech Corp. | 1991 | — |
| 0 (this device) | K993914 | Premier Toxins a&B, Model 616096 | Meridian Diagnostics, Inc. | 1999 | — |
| +1 | K033479 | Prospect Clostridium Difficile Toxin a/B Microplate Assay | Remel, Inc. | 2004 | — |
| +1 | K050891 | Tox a/B Quick Chek | Techlab, Inc. | 2005 | — |
| +1 | K082499 | C. Diff Quik Chek Complete | Techlab, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K911958 | Cytoclone a & B EiaSummary page 1…Reagents, Clostridium difficile toxin," Class I, LLH. Legally Marketed Device The predicate (previously cleared) device is the Premier Cytoclone A&B EIA, 510(k) number K911958. Concurrence date was 7/30/91. Device Description Premier Toxins A&B is an enzyme immunoassay for the direct detection of Clost… | 1991 |
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 |
|---|---|---|---|---|
| Sep 23, 2003 | Not classified | Z-0062-04 | Other | The kits were packaged with incorrect dispensing pipettes. |
| Dec 26, 2002 | Not classified | Z-0464-03 | Other | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 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?
Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clestridium difficile toxin A and toxin B in stool from patients with antibiotic associated diarrhea. Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease.
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/K993914 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993914: Premier Toxins a&B, Model 616096.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993914
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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