DEN160001 is an FDA 510(k) submission for the BD MAX Vaginal Panel, BD MAX Instrument. This device is classified as a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II - Special Controls, product code PQA).
Submitted by Geneohm Sciences Canada, Inc. (Bd Diagnostics) (Quebec, CA). The FDA issued a Not Cleared (DENG) decision on October 28, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3975. A Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Device For The Direct Detection Of Nucleic Acid Sequences From Microorganisms Associated With Vaginitis Or Bacterial Vaginosis. The Device Is Indicated For Individuals With Signs And Symptoms Of Vaginitis Or Bacterial Vaginosis And Aids In The Diagnosis Of These Vaginal Infections..
| 510(k) Number | DEN160001 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 11, 2016 |
| Decision Date | October 28, 2016 |
| Days to Decision | 291 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | PQA - Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3975 |
| Definition | A Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Device For The Direct Detection Of Nucleic Acid Sequences From Microorganisms Associated With Vaginitis Or Bacterial Vaginosis. The Device Is Indicated For Individuals With Signs And Symptoms Of Vaginitis Or Bacterial Vaginosis And Aids In The Diagnosis Of These Vaginal Infections. |