Nano-Check Influenza A+B Test
FDA 510(k) K252283 · Nano-Ditech Corporation
510(k) numberK252283
Submission
- Device name
- Nano-Check Influenza A+B Test
- Applicant
- Nano-Ditech Corporation
Cranbury, NJ, US - Received
- July 22, 2025
- Decision date
- January 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 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.
Other 510(k)s with product code PSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAPSZ · Dual Track | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 09/04/2026SE |
| 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 |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere ReaderPSZ · Special | Alere Scarborough, Inc. | 08/08/2018SE |
More from Alere Scarborough, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243561 | Nano-Check Influenza+COVID-19 Dual TestSCA · Dual Track | 06/17/2025SE |
| K240280 | Nano-Check RSV TestGQG · Dual Track | 07/30/2024SE |
| K231187 | Nano-Check COVID-19 Antigen TestQVF · Traditional | 01/23/2024SE |
| K102441 | Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and MyoglobinMMI · Special | 10/20/2010SE |
| K102131 | Nano-Check Ami Ctni Cardiac Marker TestMMI · Special | 10/20/2010SE |
| K050975 | Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB…MMI · Traditional | 03/02/2006SE |
| K050594 | Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…LDJ · Traditional | 05/15/2005SE |
Questions and answers
When was Nano-Check Influenza A+B Test cleared by the FDA?
Nano-Check Influenza A+B Test (K252283) received a 510(k) decision of Substantially Equivalent on January 15, 2026, 177 days after the submission was received.
What is the product code of K252283?
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.