K212213 is an FDA 510(k) clearance for the Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System. This device is classified as a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II - Special Controls, product code PQA).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 9, 2022, 209 days after receiving the submission on July 15, 2021.
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 | K212213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2021 |
| Decision Date | February 09, 2022 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| 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. |