510(k) K083278
K083278 is an FDA 510(k) premarket notification submitted by Arbor Vita Corportation for the device "AVC A/H5N1 FLU TEST". The FDA issued a decision of Substantially Equivalent on April 8, 2009. The device falls under product code OMS (Novel Influenza A Virus, A/H5 Ns1 Protein), a Class II device regulated under 21 CFR 866.3332.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2009
- Date Received
- November 7, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Novel Influenza A Virus, A/H5 Ns1 Protein
- Device Class
- Class II
- Regulation Number
- 866.3332
- Review Panel
- MI
- Submission Type
Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza.