K182001 is an FDA 510(k) clearance for the Acucy Influenza A&B Test with the Acucy System. This device is classified as a Devices Detecting Influenza A, B, And C Virus Antigens (Class II - Special Controls, product code PSZ).
Submitted by SEKISUI Diagnostics, LLC (San Diego, US). The FDA issued a Cleared decision on December 17, 2018, 144 days after receiving the submission on July 26, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3328. 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..
| 510(k) Number | K182001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2018 |
| Decision Date | December 17, 2018 |
| Days to Decision | 144 days |
| Submission Type | Dual Track |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PSZ - Devices Detecting Influenza A, B, And C Virus Antigens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3328 |
| Definition | 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. |