Modification to: Binaxnow Influenza a & B Test
FDA 510(k) K092223 · Binax, Inc.
510(k) numberK092223
Submission
- Device name
- Modification to: Binaxnow Influenza a & B Test
- Applicant
- Binax, Inc.
Scarborough, ME, US - Received
- July 23, 2009
- Decision date
- August 12, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K090301 | Binaxnow PBP2A Test, Model 890-000MYI · Traditional | 04/14/2010SE |
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | 02/24/2010SE |
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | 12/16/2009SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | 09/04/2009SE |
| K083744 | Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional | 09/01/2009SE |
| K080003 | Binaxnow G6PD TestJBF · Traditional | 10/23/2008SE |
| K062109 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/09/2006SE |
| K053126 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/30/2005SE |
| K041049 | Binaxnow Influenza a & B TestPSZ · Traditional | 08/10/2004SE |
| K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…GQG · Traditional | 10/21/2003SE |
Questions and answers
When was Modification to: Binaxnow Influenza a & B Test cleared by the FDA?
Modification to: Binaxnow Influenza a & B Test (K092223) received a 510(k) decision of Substantially Equivalent on August 12, 2009, 20 days after the submission was received.
What is the product code of K092223?
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.