510(k) · Cleared
Recalled · Class II · 2023Verigene C. Difficile Nucleic Acid Test (CDF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosphere, Inc. · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Dec 5, 2012 as substantially equivalent to DEN120013 (unknown applicant, ) and 2 other predicates after a 55-day review. Its family tree reaches back 4 generations to 2008. It has been recalled 4 times.
- Decided
- Dec 5, 2012
- Review
- 55 days
- Class
- Class II
- Product code
- OZN
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to DEN070013 (2008). 11 ancestors in all, the oldest K923463 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 3 generations backK081030 Modification to Proflu+ AssayProdesse, Inc. · 2008
- 2 generations backK083088 Verigene Respiratory Virus Nucleic Acid TestNanosphere, Inc. · 2009
- 1 generation backK092566 Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP…Nanosphere, Inc. · 2009
- This deviceK123197 Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −3 | K081030 | Modification to Proflu+ Assay | Prodesse, Inc. | 2008 | — |
| −2 | K083088 | Verigene Respiratory Virus Nucleic Acid Test | Nanosphere, Inc. | 2009 | — |
| −1 | K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp) | Nanosphere, Inc. | 2009 | — |
| 0 (this device) | K123197 | Verigene C. Difficile Nucleic Acid Test (CDF) | Nanosphere, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | DEN120013 | C. Difficile Nucleic Acid Amplification Test Assay Our reading of the summary gave K113358, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120013, C. Difficile Nucleic Acid Amplification Test Assay (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | |
| * | K110203 | Xpert C. Difficle/Epi AssaySummary page 2…ation for clinical multiplex test systems Predicate Devices: Portrait Toxigenic C. Dificile Assay (KI 13358) (Great Basin Scientific) Xpert C. difidile/Epi Assay (K 110203) (Cepheid) Verigene RVNAT 5 pTest (K092566) (Nanosphere) Indications for Use: The Verigene® Clostridium difficileNucleic A… | 2011 |
| * | K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)Summary page 2…redicate Devices: Portrait Toxigenic C. Dificile Assay (KI 13358) (Great Basin Scientific) Xpert C. difidile/Epi Assay (K 110203) (Cepheid) Verigene RVNAT 5 pTest (K092566) (Nanosphere) Indications for Use: The Verigene® Clostridium difficileNucleic Acid Test (CDF) is a qualitative multiplexed i… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2023 | Class II | Z-2024-2023 | Other | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic… |
| Oct 30, 2020 | Class II | Z-2010-2021 | Device Design | Potential for a false-negative result. |
| Oct 16, 2013 | Class III | Z-2168-2014 | Nonconforming Material/Component | Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in… |
| Oct 10, 2013 | Class II | Z-2682-2014 | Nonconforming Material/Component | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 1 of the 11 ancestors has a recall of any class.
- 3 other devices also cite its predicate DEN120013.
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. 2012, 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 Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR…
Read the full statement (204 words)
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
The CDF Test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF Test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123197: Verigene C. Difficile Nucleic Acid Test (CDF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123197
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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