K243345 is an FDA 510(k) clearance for the Aptima BV Assay. This device is classified as a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II - Special Controls, product code PQA).
Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on November 25, 2024, 28 days after receiving the submission on October 28, 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 | K243345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2024 |
| Decision Date | November 25, 2024 |
| Days to Decision | 28 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. |