510(k) · Cleared
ClearedSimplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Feb 14, 2017 as substantially equivalent to K130470 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2013) after a 103-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Feb 14, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- OZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923463 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 2 generations backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- 1 generation backK130470 BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · Recalled
- This deviceK163085 Simplexa C. difficile Direct; Simplexa C. difficile Positive Control…Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −2 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| −1 | K130470 | BD Max Cdiff Assay, BD Max Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013 | 2 |
| 0 (this device) | K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 2017 | — |
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 OZN? 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 OZN device
- #1 K260045 cobas® Cdiff Nucleic acid test for use on the…score 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K130470 | BD Max Cdiff Assay, BD Max InstrumentSummary page 4…stridium difficile toxin gene amplification assay Class II Special Controls Predicate Device BD MAX CDIFF ASSAY (K130470) Intended Use Simplexa™ C. difficile Direct (MOL2950) The Focus Diagnostics Simplexa™ C. difficile Direct assay is intended fo… | 2013 |
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 24 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130470.
How does its category compare?
All OZN devicesOZN C. Difficile Toxin Gene Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OZN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZN
89in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OZN
3in 2025
MAUDE reports naming product code OZN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 4 | 79 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 5 | 89 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 1 | 7 |
| 2025 | 1 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Focus Diagnostics Simplexa™ C. difficile Direct assay is intended for use on the Integrated Cycler instrument for the detection of Clostridium difficile toxin B gene (tcdB) present in liquid or unformed stool samples from individuals suspected of C. difficile infection (CDI). This test aids in the diagnosis of illness resulting from CDI.
The assay is for professional and prescription use only.
The Simplexa™ C. difficile Positive Control Pack is intended to be used as a control with the Simplexa™ C. difficile Direct kit.
This control is not intended for use with other assays or systems.
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/K163085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163085: Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163085
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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