510(k) K140851
K140851 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL". The FDA issued a decision of Substantially Equivalent on April 25, 2014. The device falls under product code OEP (Influenza A Virus Subtype Differentiation Nucleic Acid Assay), a Class II device regulated under 21 CFR 866.3980. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2014
- Date Received
- April 3, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Influenza A Virus Subtype Differentiation Nucleic Acid Assay
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.