510(k) · Cleared
ClearedSimplexa C. Difficile Universal Direct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc. · OMN C. Difficile Nucleic Acid Amplification Test Assay
Cleared on Apr 4, 2012 as substantially equivalent to K110012 (Meridian Bioscience, Inc., 2011) and 1 other predicate after a 135-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Apr 4, 2012
- Review
- 135 days
- Class
- Class I
- Product code
- OMN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K923463 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 4 generations backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- 3 generations backK091109 Xpert C. DifficileCepheid · 2009
- 2 generations backK100818 Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile…Meridian Bioscience, Inc. · 2010
- 1 generation backK110012 Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. · 2011 · Recalled
- This deviceK113433 Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −4 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| −3 | K091109 | Xpert C. Difficile | Cepheid | 2009 | — |
| −2 | K100818 | Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External… | Meridian Bioscience, Inc. | 2010 | — |
| −1 | K110012 | Illumigene C. Difficile, and Illumipro-10 | Meridian Bioscience, Inc. | 2011 | 2 |
| 0 (this device) | K113433 | Simplexa C. Difficile Universal Direct | Focus Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 OMN? 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? (2)
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 |
|---|---|---|---|
| * | K110012 | Illumigene C. Difficile, and Illumipro-10Summary page 1…C.difficile nucleic acid Classification Class I Predicate Devices illumigene TM C. difficole (K1 10012) BID Geneahm TM Cdiff (K081920) Intended Use The Focus Diagnostics Simplexa T" C. dif… | 2011 |
| * | K081920 | BD Geneohm Cdiff AssaySummary page 1…Class I Predicate Devices illumigene TM C. difficole (K1 10012) BID Geneahm TM Cdiff (K081920) Intended Use The Focus Diagnostics Simplexa T" C. difficile Universal Direct is a real-time polymerase chain reaction (POR) ass… | 2008 |
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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All OMN devicesOMN C. Difficile Nucleic Acid Amplification Test Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OMN
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OMN
Too few OMN 510(k)s in any year since 2007 to give a median.
Recalls per year · OMN
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMN
No MAUDE report names OMN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Focus Diagnostics SimplexaTM C. dtfficile Universal Direct is a real-time polymerase chain reaction (PCR) assay and is intended for use on the 3M Integrated Cycler instrument for the detection of toiigenic Clostridium dificile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection. This test aids in the diagnosis of Clostridium difficile associated disease (CDAD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113433: Simplexa C. Difficile Universal Direct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113433
Report an extraction error
Are you the manufacturer?
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