K243725 is an FDA 510(k) clearance for the BD Vaginal Panel. This device is classified as a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II - Special Controls, product code PQA).
Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on December 19, 2024, 16 days after receiving the submission on December 3, 2024.
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 | K243725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |