510(k) K212727
K212727 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "FilmArray Pneumonia Panel". The FDA issued a decision of Substantially Equivalent on September 22, 2021. The device falls under product code QDP (Respiratory Panel), a Class II device regulated under 21 CFR 866.3985. Biofire Diagnostics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2021
- Date Received
- August 27, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Panel
- Device Class
- Class II
- Regulation Number
- 866.3985
- Review Panel
- MI
- Submission Type
The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection.