Xpert Flu Genexpert DX Systems (Gx-I, Gx-Iv)
FDA 510(k) K120911 · Cepheid
510(k) numberK120911
Submission
- Device name
- Xpert Flu Genexpert DX Systems (Gx-I, Gx-Iv)
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- March 26, 2012
- Decision date
- May 18, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQW – 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3332
- Specialty
- Microbiology
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens
Other 510(k)s with product code OQW
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|---|---|---|---|
| K132237 | Prodesse Profast+ AssayOQW · Special | Gen-Probe Prodesse, Inc. | 08/26/2013SE |
| K130551 | CDC Human Influenza Virus Real-Time Rt-Pcr Diagnostic PanelOQW · Traditional | Centers for Disease Control and Prevention | 05/22/2013SE |
| K123905 | CDC Human Influenza Virus Real-Time Rt-Pcr Diagnostic PanelOQW · Special | Centers for Disease Control and Prevention | 01/14/2013SE |
| K111778 | Jbaids Influenza a Subtyping KitOQW · Traditional | U.S Army Medical Materiel Development Activity | 09/13/2011SE |
| K111507 | CDC Human Influenza Virus Real-Time Rt-Pcr Diagnostic PanelOQW · Traditional | Centers for Disease Control and Prevention | 08/23/2011SE |
| K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…OQW · Traditional | Cepheid | 04/21/2011SE |
| K101855 | Profast+ AssayOQW · Traditional | Gen-Probe Prodesse, Inc. | 07/23/2010SE |
| K101564 | CDC Influenza 2009 A(H1N1)PDM Real-Time Rt-Pcr PanelOQW · Traditional | Centers for Disease Control and Prevention | 06/22/2010SE |
| K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500OQW · Traditional | Focus Diagnostics, Inc. | 05/24/2010SE |
More from Focus Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K253653 | Xpert Hemorrhagic Fever · Traditional | 02/20/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
Questions and answers
When was Xpert Flu Genexpert DX Systems (Gx-I, Gx-Iv) cleared by the FDA?
Xpert Flu Genexpert DX Systems (Gx-I, Gx-Iv) (K120911) received a 510(k) decision of Substantially Equivalent on May 18, 2012, 53 days after the submission was received.
What is the product code of K120911?
The FDA product code is OQW – 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification, a Class II (moderate risk) device regulated under 21 CFR 866.3332.