DEN200066 is an FDA 510(k) submission for the BioFire Joint Infection (JI) Panel. This device is classified as a Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System (Class II - Special Controls, product code QSN).
Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on April 29, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3988. A Qualitative Nucleic Acid Assay That Detects And Identifies Microbial Organisms And Antimicrobial Resistance Markers In Clinical Specimens To Aid In The Diagnosis Of Orthopedic Infections..
| 510(k) Number | DEN200066 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 27, 2020 |
| Decision Date | April 29, 2022 |
| Days to Decision | 549 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | QSN — Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3988 |
| Definition | A Qualitative Nucleic Acid Assay That Detects And Identifies Microbial Organisms And Antimicrobial Resistance Markers In Clinical Specimens To Aid In The Diagnosis Of Orthopedic Infections. |