510(k) K212727

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.