C. Difficile Toxin Gene Amplification Assay
The C. difficile Toxin Gene Amplification Assay is an in vitro diagnostic amplification assay for the detection of Clostridioides difficile toxin genes from stool specimens of symptomatic patients, aiding in the diagnosis of C. difficile infection. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZN, with regulation number 866.3130 under the Microbiology medical specialty.
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Basic Information
- Product Code
- OZN
- Device Class
- FDA class 2
- Regulation Number
- 866.3130
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243730 | Xpert C. difficile/Epi | Feb 28, 2025 | Substantially Equivalent | Cepheid® |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Nov 14, 2023 | Substantially Equivalent | Vela Operations USA |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Oct 20, 2021 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Sep 09, 2021 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K172569 | GenePOC CDiff | Nov 22, 2017 | Substantially Equivalent | Genepoc, Inc. |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Sep 12, 2017 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit | Jul 21, 2017 | Substantially Equivalent | Luminex Corporation |
| K170491 | Solana C. difficile Assay | May 11, 2017 | Substantially Equivalent | Quidel Corporation |
| K163085 | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack | Feb 14, 2017 | Substantially Equivalent | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC |
| K142422 | cobas Cdiff Test | May 20, 2015 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | Apr 04, 2014 | Substantially Equivalent | QIAGEN GmbH |
| K132726 | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM | Nov 29, 2013 | Substantially Equivalent | Primeradx |
| K132235 | IMDX C.DIFFICILE FOR ABBOTT M2000 | Oct 11, 2013 | Substantially Equivalent | Intelligent Medical Devices, Inc. |
| K130470 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | Apr 02, 2013 | Substantially Equivalent | Geneohm Sciences Canada, Inc. (Bd Diagnostics) |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Mar 08, 2013 | Substantially Equivalent | Quidel Corp. |
| K123355 | AMPLIVUE C. DIFFICILE ASSAY | Dec 13, 2012 | Substantially Equivalent | Quidel Corporation |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | Dec 05, 2012 | Substantially Equivalent | Nanosphere, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.