FDA product code OQW: 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
OQW is the FDA product code for 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification. It is a Class II device, regulated under 21 CFR 866.3332 and reviewed by the Microbiology panel. FDA has cleared 10 510(k) submissions under OQW, from 5 different applicants. The average 510(k) review took 65 days (median 66).
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
Classification
| Field | Value |
|---|---|
| Device name | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Device class | Class II |
| Regulation | 21 CFR 866.3332 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OQW clearance
Top OQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centers for Disease Control and Prevention | 4 | 2013-05-22 |
| Gen-Probe Prodesse, Inc. | 2 | 2013-08-26 |
| Cepheid | 2 | 2012-05-18 |
| U.S Army Medical Materiel Development Activity | 1 | 2011-09-13 |
| Focus Diagnostics, Inc. | 1 | 2010-05-24 |
Most recent OQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132237 | Gen-Probe Prodesse, Inc. | PRODESSE PROFAST+ ASSAY | 2013-08-26 | 39 |
| K130551 | Centers for Disease Control and Prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | 2013-05-22 | 79 |
| K123905 | Centers for Disease Control and Prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | 2013-01-14 | 26 |
| K120911 | Cepheid | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) | 2012-05-18 | 53 |
| K111778 | U.S Army Medical Materiel Development Activity | JBAIDS INFLUENZA A SUBTYPING KIT | 2011-09-13 | 82 |
Recalls for OQW devices
openFDA lists no recalls for product code OQW.
Frequently asked questions
What is FDA product code OQW?
OQW is the FDA product code for 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification. It is a Class II device, regulated under 21 CFR 866.3332 and reviewed by the Microbiology panel.
What device class is OQW?
Class II, regulation 21 CFR 866.3332. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQW?
Across 10 cleared submissions the average was 65 days from receipt to decision (median 66).
Which companies have the most OQW clearances?
Centers for Disease Control and Prevention (4); Gen-Probe Prodesse, Inc. (2); Cepheid (2); U.S Army Medical Materiel Development Activity (1); Focus Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OQW
- Run a recall and safety report across every OQW manufacturer
- Watch product code OQW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times