510(k) DEN200066
DEN200066 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "BioFire Joint Infection (JI) Panel". The FDA issued a decision of De Novo Granted on April 29, 2022. The device falls under product code QSN (Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.3988. Biofire Diagnostics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 29, 2022
- Date Received
- October 27, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3988
- Review Panel
- MI
- Submission Type
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.