OZN — C. Difficile Toxin Gene Amplification Assay Class II
FDA product code OZN covers "C. Difficile Toxin Gene Amplification Assay", a Class II medical device regulated under 21 CFR 866.3130. Submissions are reviewed by the Microbiology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OZN
- Device Class
- Class II
- Regulation Number
- 866.3130
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243730 | cepheid® | Xpert C. difficile/Epi | February 28, 2025 |
| K232092 | vela operations usa | Great Basin Toxigenic C. difficile Direct Test (CDF2) | November 14, 2023 |
| K212427 | roche molecular systems | cobas Cdiff nucleic acid test for use on the cobas Liat System | October 20, 2021 |
| K210385 | roche molecular systems | cobas Cdiff nucleic acid test for use on the cobas Liat System | September 9, 2021 |
| K172569 | genepoc | GenePOC CDiff | November 22, 2017 |
| K171770 | roche molecular systems | cobas Cdiff Nucleic acid test for use on the cobas Liat System | September 12, 2017 |
| K171441 | luminex corporation | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki | July 21, 2017 |
| K170491 | quidel corporation | Solana C. difficile Assay | May 11, 2017 |
| K163085 | focus diagnostics, inc.:dba diasorin molecular | Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack | February 14, 2017 |
| K142422 | roche molecular systems | cobas Cdiff Test | May 20, 2015 |
| K133936 | qiagen | ARTUS C. DIFFICILE QS-RGQ MDX KIT | April 4, 2014 |
| K132726 | primeradx | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM | November 29, 2013 |
| K132235 | intelligent medical devices | IMDX C.DIFFICILE FOR ABBOTT M2000 | October 11, 2013 |
| K130470 | geneohm sciences canada, inc. (bd diagnostics) | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT | April 2, 2013 |
| K123998 | quidel | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | March 8, 2013 |
| K123355 | quidel corporation | AMPLIVUE C. DIFFICILE ASSAY | December 13, 2012 |
| K123197 | nanosphere | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | December 5, 2012 |