BD Vaginal Panel
FDA 510(k) clearance K223653 · decided 2023-03-06
Clearance details
- K-number
- K223653
- Device name
- BD Vaginal Panel
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2022-12-06
- Decision date
- 2023-03-06
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PQA
- Device class
- 2
- Regulation number
- 866.3975
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| BD Vaginal Panel (K243725) | Becton, Dickinson and Company | 2024-12-19 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Xpert Xpress MVP; GeneXpert Xpress System (K231381) | Cepheid | 2023-10-19 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K221160) | Cepheid | 2022-06-07 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K212213) | Cepheid | 2022-02-09 |
| BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (K201017) | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 |
| BD MAX Vaginal Panel (K191957) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 |
| Aptima BV Assay (K190452) | Hologic, Inc. | 2019-05-23 |
| Aptima CV/TV Assay (K190472) | Hologic, Inc. | 2019-05-16 |
| BD MAX Vaginal Panel, BD MAX Instrument (DEN160001) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |
| BD Onclarity HPV Assay (P160037/S019) | Becton, Dickinson and Company | 2024-04-18 |
| BD Onclarity HPV Assay (P160037/S018) | Becton, Dickinson and Company | 2023-11-20 |
| BD Onclarity HPV (P160037/S016) | Becton, Dickinson and Company | 2023-11-15 |