OQW · 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Microbiology · 21 CFR 866.3332 · Class 2
Overview
| Product Code | OQW |
|---|---|
| Device Name | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Regulation | 21 CFR 866.3332 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Reagents for detection of specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNA aids in the diagnosis of influenza caused by specific novel influenza A viruses in patients with clinical risk of infection with these viruses, and also aids in the presumptive laboratory identification of specific novel influenza A viruses to provide epidemiological information on influenza. These reagents include primers, probes, and specific influenza A virus controls.
Classification Rationale
Class II (special controls). The special controls are:
Special Controls
The device is classified as Class II under regulation 21 CFR 866.3332 with special controls. The special control guidance document "Reagents for Detection of Specific Novel Influenza A viruses" will be available shortly.
*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses.” See § 866.1(e) for information on obtaining this document. (2) The distribution of these devices is limited to laboratories with experienced personnel who have training in standardized molecular testing procedures and expertise in viral diagnosis, and appropriate biosafety equipment and containment.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132237 | PRODESSE PROFAST+ ASSAY | Gen-Probe Prodesse, Inc. | Aug 26, 2013 | SESE |
| K130551 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | May 22, 2013 | SESE |
| K123905 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | Jan 14, 2013 | SESE |
| K120911 | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) | Cepheid | May 18, 2012 | SESE |
| K111778 | JBAIDS INFLUENZA A SUBTYPING KIT | U.S Army Medical Materiel Development Activity | Sep 13, 2011 | SESE |
| K111507 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | Aug 23, 2011 | SESE |
| K103766 | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 | Cepheid | Apr 21, 2011 | SESE |
| K101855 | PROFAST+ ASSAY | Gen-Probe Prodesse, Inc. | Jul 23, 2010 | SESE |
| K101564 | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL | Centers for Disease Control and Prevention | Jun 22, 2010 | SESE |
| K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 | Focus Diagnostics, Inc. | May 24, 2010 | SESE |
Top Applicants
- Centers for Disease Control and Prevention — 4 clearances
- Cepheid — 2 clearances
- Gen-Probe Prodesse, Inc. — 2 clearances
- Focus Diagnostics, Inc. — 1 clearance
- U.S Army Medical Materiel Development Activity — 1 clearance
