510(k) K180966
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2018
- Date Received
- April 13, 2018
- Clearance Type
- Traditional
- 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.