cobas® BV/CV
FDA 510(k) K260021 · Roche Molecular Systems, Inc.
510(k) numberK260021
Submission
- Device name
- cobas® BV/CV
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- January 5, 2026
- Decision date
- July 16, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PQA – Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3975
- Specialty
- Microbiology
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.
Other 510(k)s with product code PQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243725 | BD Vaginal PanelPQA · Special | Becton, Dickinson and Company | 12/19/2024SE |
| K243345 | Aptima BV Assay; Aptima CV/TV AssayPQA · Special | Hologic, Inc. | 11/25/2024SE |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress SystemPQA · Dual Track | Cepheid | 10/19/2023SE |
| K223653 | BD Vaginal PanelPQA · Traditional | Becton, Dickinson and Company | 03/06/2023SE |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Special | Cepheid | 06/07/2022SE |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Traditional | Cepheid | 02/09/2022SE |
| K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitPQA · Traditional | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 10/18/2021SE |
| K191957 | BD MAX Vaginal PanelPQA · Traditional | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 10/21/2019SE |
| K190452 | Aptima BV AssayPQA · Traditional | Hologic, Inc. | 05/23/2019SE |
| K190472 | Aptima CV/TV AssayPQA · Traditional | Hologic, Inc. | 05/16/2019SE |
More from Hologic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional | 08/28/2026SE |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | 08/28/2026SE |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional | 07/08/2026SE |
| K253759 | cobas liat CT/NG/MG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K253756 | cobas liat CT/NG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K243753 | cobas liat Bordetella panel nucleic acid testOZZ · Dual Track | 11/20/2025SE |
| K252484 | cobas HCVMZP · Traditional | 11/03/2025SE |
| K252481 | cobas CMVPAB · Traditional | 11/03/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | 07/31/2025SE |
| K243863 | Opulus Lymphoma PrecisionQIH · Traditional | 05/30/2025SE |
Questions and answers
When was cobas® BV/CV cleared by the FDA?
cobas® BV/CV (K260021) received a 510(k) decision of Substantially Equivalent on July 16, 2026, 192 days after the submission was received.
What is the product code of K260021?
The FDA product code is PQA – Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, a Class II (moderate risk) device regulated under 21 CFR 866.3975.