OZE — Influenza A And Influenza B Multiplex Nucleic Acid Assay Class II
FDA product code OZE covers "Influenza A And Influenza B Multiplex Nucleic Acid Assay", a Class II medical device regulated under 21 CFR 866.3980. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OZE
- Device Class
- Class II
- Regulation Number
- 866.3980
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243274 | centers for disease control and prevention | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typin | July 11, 2025 |
| K243931 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin | March 14, 2025 |
| K241110 | centers for disease control and prevention | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtypi | May 21, 2024 |
| K230236 | quidel corporation | Lyra Influenza A+B Assay | March 3, 2023 |
| K220801 | abbott diagnostics scarborough | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | June 24, 2022 |
| K200370 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin | March 10, 2020 |
| K182513 | indevr | FluChip-8G Influenza A+B Assay | April 22, 2019 |
| K190302 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin | March 27, 2019 |
| K190204 | alere scarborough | ID NOW Influenza A & B 2 | March 18, 2019 |
| K181736 | centers for disease control and prevention (cdc) | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage | July 30, 2018 |
| K171641 | mesa biotech | Accula Flu A/Flu B Test | February 6, 2018 |
| K172091 | centers for disease control and prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin | August 9, 2017 |
| K161556 | centers for disease control and prevention (cdc) | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtypi | June 30, 2016 |
| K153148 | centers for disease control and prevention (cdc) | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Sub | December 1, 2015 |
| K141859 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBT | August 1, 2014 |
| K140857 | centers for disease control and prevention | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR D | April 25, 2014 |
| K133869 | center for disease control and prevention (cdc) | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPIN | January 17, 2014 |
| K132508 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | September 23, 2013 |
| K131728 | quidel | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | August 29, 2013 |
| K113777 | quidel | QUIDEL MOLECULAR INFLUENZA A+B | March 15, 2012 |