510(k) K163628
K163628 is an FDA 510(k) premarket notification submitted by Janssen Pharmaceutica NV for the device "Idylla Respiratory (IFV-RSV) Panel". The FDA issued a decision of Substantially Equivalent on Aug 30, 2017. The device falls under product code OCC (Respiratory Virus Panel Nucleic Acid Assay System), a Class II device regulated under 21 CFR 866.3980. Janssen Pharmaceutica NV has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 30, 2017
- Date Received
- Dec 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Virus Panel Nucleic Acid Assay System
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
- 510(k)
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.