K170491 is an FDA 510(k) clearance for the Solana C. difficile Assay. This device is classified as a C. Difficile Toxin Gene Amplification Assay (Class II - Special Controls, product code OZN).
Submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on May 11, 2017, 83 days after receiving the submission on February 17, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3130. Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients..
| 510(k) Number | K170491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2017 |
| Decision Date | May 11, 2017 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OZN — C. Difficile Toxin Gene Amplification Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3130 |
| Definition | Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients. |