K103766 is an FDA 510(k) clearance for the XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0. This device is classified as a 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II - Special Controls, product code OQW).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 21, 2011, 119 days after receiving the submission on December 23, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3332. 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens.
| 510(k) Number | K103766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2010 |
| Decision Date | April 21, 2011 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OQW — 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3332 |
| Definition | 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens |