510(k) K161556
K161556 is an FDA 510(k) premarket notification submitted by Centers For Disease Control and Prevention (CDC) for the device "CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit". The FDA issued a decision of Substantially Equivalent on June 30, 2016. 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. Centers For Disease Control and Prevention (CDC) has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2016
- Date Received
- June 6, 2016
- Clearance Type
- Special
- 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.