K191514 is an FDA 510(k) clearance for the CareStart Flu A&B Plus. This device is classified as a Devices Detecting Influenza A, B, And C Virus Antigens (Class II - Special Controls, product code PSZ).
Submitted by Access Bio, Inc. (Somerset, US). The FDA issued a Cleared decision on February 18, 2020, 256 days after receiving the submission on June 7, 2019.
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 | K191514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2019 |
| Decision Date | February 18, 2020 |
| Days to Decision | 256 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. |