C. Difficile Toxin Gene Amplification Assay
FDA product code OZN · Class II (moderate risk) · 21 CFR 866.3130 · Microbiology
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
18510(k) clearances
0PMA approvals
8recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | Roche Molecular Systems, Inc. | 08/28/2026SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | Cepheid® | 02/28/2025SE |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2)OZN · Traditional | Vela Operations USA | 11/14/2023SE |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat SystemOZN · Special | Roche Molecular Systems, Inc. | 10/20/2021SE |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat SystemOZN · Special | Roche Molecular Systems, Inc. | 09/09/2021SE |
| K172569 | GenePOC CDiffOZN · Traditional | Genepoc, Inc. | 11/22/2017SE |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZN · Traditional | Roche Molecular Systems, Inc. | 09/12/2017SE |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional | Luminex Corporation | 07/21/2017SE |
| K170491 | Solana C. difficile AssayOZN · Traditional | Quidel Corporation | 05/11/2017SE |
| K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackOZN · Traditional | Focus Diagnostics, Inc.:Dba Diasorin Molecular… | 02/14/2017SE |
| K142422 | cobas Cdiff TestOZN · Traditional | Roche Molecular Systems, Inc. | 05/20/2015SE |
| K133936 | Artus C. Difficile Qs-Rgq MDX KitOZN · Traditional | QIAGEN GmbH | 04/04/2014SE |
| K132726 | Iceplex C. Difficile Assay Kit, Iceplex SystemOZN · Traditional | Primeradx | 11/29/2013SE |
| K132235 | Imdx C.Difficile for Abbott M2000OZN · Traditional | Intelligent Medical Devices, Inc. | 10/11/2013SE |
| K130470 | BD Max Cdiff Assay, BD Max InstrumentOZN · Traditional | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 04/02/2013SE |
| K123998 | Quidel Molecular Direct C. Difficile AssayOZN · Traditional | Quidel Corp. | 03/08/2013SE |
| K123355 | Amplivue C. Difficile AssayOZN · Traditional | Quidel Corporation | 12/13/2012SE |
| K123197 | Verigene C. Difficile Nucleic Acid Test (CDF)OZN · Traditional | Nanosphere, Inc. | 12/05/2012SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1019-2026 Class II | Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene…The affected lots show a decline in performance over time, which may lead to false-negative results. | Meridian Bioscience Inc | 12/05/2025Open, Classified |
| Z-0238-2026 Class II | BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX…Product service credentials used by some BD technical support teams to access certain BD products were… | Becton Dickinson & Co. | 09/23/2025Open, Classified |
| Z-0590-2025 Class II | BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | Becton Dickinson & Co. | 10/31/2024Open, Classified |
| Z-2024-2023 Class II | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the… | Luminex Corporation | 06/05/2023Open, Classified |
| Z-1334-2022 Class II | Verigene CDF Nucleic Acid Test, Part No. 30-002-22There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP… | Luminex Corporation | 06/17/2022Open, Classified |
| Z-2287-2019 Class II | ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | Luminex Corporation | 02/20/2019Open, Classified |
| Z-2168-2014 Class III | Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a…Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal… | Nanosphere, Inc. | 10/16/2013Terminated |
| Z-2682-2014 Class II | The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | Nanosphere, Inc. | 10/10/2013Terminated |