ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
FDA 510(k) K220801 · Abbott Diagnostics Scarborough, Inc.
Submission
- Device name
- ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
- Applicant
- Abbott Diagnostics Scarborough, Inc.
Scarborough, ME, US - Received
- March 18, 2022
- Decision date
- June 24, 2022
- 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0OCC · Special | 08/31/2026SE |
| K250273 | BinaxNOW COVID-19 Ag CardQVF · Dual Track | 06/13/2025SE |
| K243518 | BinaxNOW COVID-19 Antigen Self TestQYT · Traditional | 02/11/2025SE |
| K232775 | ID NOW Influenza A & B 2OCC · Special | 10/10/2023SE |
| K221925 | Id Now COVID-19 2.0QWR · Dual Track | 08/10/2023SE |
| K191534 | ID NOW Influenza A & B 2OCC · Special | 07/11/2019SE |
Questions and answers
When was ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 cleared by the FDA?
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (K220801) received a 510(k) decision of Substantially Equivalent on June 24, 2022, 98 days after the submission was received.
What is the product code of K220801?
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.