510(k) · Cleared
Recalled · Class II · 2025GenePOC CDiff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genepoc, Inc. · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Nov 22, 2017 as substantially equivalent to K130470 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2013) after an 89-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 22, 2017
- Review
- 89 days
- Class
- Class II
- Product code
- OZN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923463 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK172569 GenePOC CDiffGenepoc, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK232092 Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA · 2023
Most influential descendants
Showing 1 of 1 · See all- K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA · 2023 · cites it directly0descendants
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) | K172569 | GenePOC CDiff | Genepoc, Inc. | 2017 | — |
| +1 | K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 6…remarket Notification H. SUBSTANTIAL EQUIVALENCE INFORMATION: 1. Predicate Device Name: BD MAX CDIFF ASSAY, BD MAX INSTRUMENT 2. Predicate 510(k) Number: K130470 3. Comparison with Predicate: Item GenePOC™ CDiff BD MAX Cdiff Assay (Predicat… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2025 | Class II | Z-1019-2026 | Under Investigation by firm | The affected lots show a decline in performance over time, which may lead to false-negative results. |
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 4.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K232092 (Vela Operations USA, 2023) has gone furthest, with 0 descendants of its own.
- 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 GenePOC CDiff assay performed on the revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI.
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/K172569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172569: GenePOC CDiff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172569
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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