K130470 is an FDA 510(k) clearance for the BD MAX CDIFF ASSAY, BD MAX INSTRUMENT. This device is classified as a C. Difficile Toxin Gene Amplification Assay (Class II - Special Controls, product code OZN).
Submitted by Geneohm Sciences Canada, Inc. (Bd Diagnostics) (Quebec, CA). The FDA issued a Cleared decision on April 2, 2013, 36 days after receiving the submission on February 25, 2013.
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 | K130470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2013 |
| Decision Date | April 02, 2013 |
| Days to Decision | 36 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. |