K171441 is an FDA 510(k) clearance for the ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit. This device is classified as a C. Difficile Toxin Gene Amplification Assay (Class II - Special Controls, product code OZN).
Submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on July 21, 2017, 66 days after receiving the submission on May 16, 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 | K171441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2017 |
| Decision Date | July 21, 2017 |
| Days to Decision | 66 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. |