510(k) K182513
K182513 is an FDA 510(k) premarket notification submitted by Indevr, Inc. for the device "FluChip-8G Influenza A+B Assay". The FDA issued a decision of Substantially Equivalent on April 22, 2019. The device falls under product code OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay), a Class II device regulated under 21 CFR 866.3980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2019
- Date Received
- September 12, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.