CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
FDA 510(k) K241110 · Centers for Disease Control and Prevention
Submission
- Device name
- CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- Applicant
- Centers for Disease Control and Prevention
Atlanta, GA, US - Received
- April 22, 2024
- Decision date
- May 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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…
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|---|---|---|---|
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 07/11/2025SE |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 03/14/2025SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | Quidel Corporation | 03/03/2023SE |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2OZE · Special | Abbott Diagnostics Scarborough, Inc. | 06/24/2022SE |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Special | Centers for Disease Control and Prevention | 03/10/2020SE |
| K182513 | FluChip-8G Influenza A+B AssayOZE · Traditional | Indevr, Inc. | 04/22/2019SE |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Traditional | Centers for Disease Control and Prevention | 03/27/2019SE |
| K190204 | ID NOW Influenza A & B 2OZE · Special | Alere Scarborough, Inc. | 03/18/2019SE |
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…OZE · Special | Centers For Disease Control and Prevention (CDC) | 07/30/2018SE |
| K171641 | Accula Flu A/Flu B TestOZE · Dual Track | Mesa Biotech, Inc. | 02/06/2018SE |
More from Mesa Biotech, Inc.
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| K252072 | Francisella tularensis Real-time PCR assaySGA · Traditional | 09/30/2025SE |
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | 07/11/2025SE |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…OZE · Traditional | 03/14/2025SE |
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Special | 08/30/2022SE |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Special | 06/24/2022SE |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetPBK · Traditional | 06/10/2022SE |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Special | 03/10/2020SE |
| K192871 | B. anthracis Real-time PCR AssayNHT · Special | 11/07/2019SE |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…OZE · Traditional | 03/27/2019SE |
Questions and answers
When was CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) cleared by the FDA?
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) (K241110) received a 510(k) decision of Substantially Equivalent on May 21, 2024, 29 days after the submission was received.
What is the product code of K241110?
The FDA product code is OZE – Influenza A And Influenza B Multiplex Nucleic Acid Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3980.