Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k) K212213 · Cepheid
Submission
- Device name
- Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- July 15, 2021
- Decision date
- February 9, 2022
- 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 |
|---|---|---|---|
| K260021 | cobas® BV/CVPQA · Traditional | Roche Molecular Systems, Inc. | 07/16/2026SE |
| 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 |
| 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 |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K253653 | Xpert Hemorrhagic Fever · Traditional | 02/20/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
Questions and answers
When was Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System cleared by the FDA?
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K212213) received a 510(k) decision of Substantially Equivalent on February 9, 2022, 209 days after the submission was received.
What is the product code of K212213?
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.