510(k) DEN060008
DEN060008 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET". The FDA issued a decision of De Novo Granted on February 3, 2006. The device falls under product code NXD (Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna), a Class II device regulated under 21 CFR 866.3332. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 3, 2006
- Date Received
- January 27, 2006
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
- Device Class
- Class II
- Regulation Number
- 866.3332
- Review Panel
- MI
- Submission Type
Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments 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. These reagents are primers and probes, along with a specific novel influenza virus control.