Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
FDA 510(k) K162642 · Alere Scarborough, Inc.
510(k) numberK162642
Submission
- Device name
- Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
- Applicant
- Alere Scarborough, Inc.
Scarborough, ME, US - Received
- September 22, 2016
- Decision date
- April 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSZ – Devices Detecting Influenza A, B, And C Virus Antigens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3328
- Specialty
- Microbiology
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
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| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAPSZ · Dual Track | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 09/04/2026SE |
| K252283 | Nano-Check Influenza A+B TestPSZ · Dual Track | Nano-Ditech Corporation | 01/15/2026SE |
| K250398 | Innovita Flu A/B Antigen Rapid TestPSZ · Traditional | Innovita (Tangshan) Biological Technology Co.… | 07/03/2025SE |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 SystemPSZ · Dual Track | SEKISUI Diagnostics, LLC | 04/18/2025SE |
| K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived KitPSZ · Traditional | Bd | 12/05/2023SE |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ · Traditional | Bd | 01/27/2023SE |
| K192719 | Osom Ultra Plus Flu A&B Test KitPSZ · Dual Track | SEKISUI Diagnostics, LLC | 04/03/2020SE |
| K191514 | CareStart Flu A&B PlusPSZ · Dual Track | Access Bio, Inc. | 02/18/2020SE |
| K182001 | Acucy Influenza A&B Test with the Acucy SystemPSZ · Dual Track | SEKISUI Diagnostics, LLC | 12/17/2018SE |
| K182157 | BioSign Flu A+BPSZ · Special | Princeton BioMeditech Corp. | 09/18/2018SE |
More from Princeton BioMeditech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K190204 | ID NOW Influenza A & B 2OZE · Special | 03/18/2019SE |
| 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 |
| 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 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit cleared by the FDA?
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K162642) received a 510(k) decision of Substantially Equivalent on April 10, 2017, 200 days after the submission was received.
What is the product code of K162642?
The FDA product code is PSZ – Devices Detecting Influenza A, B, And C Virus Antigens, a Class II (moderate risk) device regulated under 21 CFR 866.3328.