510(k) K103766
K103766 is an FDA 510(k) premarket notification submitted by Cepheid for the device "XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0". The FDA issued a decision of Substantially Equivalent on April 21, 2011. The device falls under product code OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification), a Class II device regulated under 21 CFR 866.3332. Cepheid has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2011
- Date Received
- December 23, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- Device Class
- Class II
- Regulation Number
- 866.3332
- Review Panel
- MI
- Submission Type
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens