ID NOW Influenza A & B 2
FDA 510(k) K190204 · Alere Scarborough, Inc.
510(k) numberK190204
Submission
- Device name
- ID NOW Influenza A & B 2
- Applicant
- Alere Scarborough, Inc.
Scarborough, ME, US - Received
- February 4, 2019
- Decision date
- March 18, 2019
- 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…
Other 510(k)s with product code OZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…OZE · Special | Centers for Disease Control and Prevention | 05/21/2024SE |
| 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere ReaderPSZ · Special | 08/08/2018SE |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitPGX · Dual Track | 05/02/2018SE |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2OCC · Special | 01/26/2018SE |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…PSZ · Special | 12/13/2017SE |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC · Traditional | 09/29/2017SE |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…PSZ · Traditional | 04/10/2017SE |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentOCC · Special | 12/21/2016SE |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitOCC · Traditional | 08/18/2016SE |
| K161364 | BinaxNOW G6PD TestJBF · Special | 06/17/2016SE |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC · Traditional | 07/28/2015SE |
Questions and answers
When was ID NOW Influenza A & B 2 cleared by the FDA?
ID NOW Influenza A & B 2 (K190204) received a 510(k) decision of Substantially Equivalent on March 18, 2019, 42 days after the submission was received.
What is the product code of K190204?
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.