PQA — Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Class II
FDA product code PQA covers "Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System", a Class II medical device regulated under 21 CFR 866.3975. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PQA
- Device Class
- Class II
- Regulation Number
- 866.3975
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260021 | roche molecular systems | cobas® BV/CV | July 16, 2026 |
| K243725 | becton, dickinson and | BD Vaginal Panel | December 19, 2024 |
| K243345 | hologic | Aptima BV Assay; Aptima CV/TV Assay | November 25, 2024 |
| K231381 | cepheid | Xpert Xpress MVP; GeneXpert Xpress System | October 19, 2023 |
| K223653 | becton, dickinson and | BD Vaginal Panel | March 6, 2023 |
| K221160 | cepheid | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | June 7, 2022 |
| K212213 | cepheid | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | February 9, 2022 |
| K201017 | geneohm sciences canada, inc. (bd life sciences) | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | October 18, 2021 |
| K191957 | geneohm sciences canada, inc. (bd diagnostics) | BD MAX Vaginal Panel | October 21, 2019 |
| K190452 | hologic | Aptima BV Assay | May 23, 2019 |
| K190472 | hologic | Aptima CV/TV Assay | May 16, 2019 |
| DEN160001 | geneohm sciences canada, inc. (bd diagnostics) | BD MAX Vaginal Panel, BD MAX Instrument | October 28, 2016 |