K181473 is an FDA 510(k) clearance for the DENV Detect NS1 ELISA. This device is classified as a Dengue Virus Antigen Assay (Class II - Special Controls, product code QCU).
Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on August 27, 2018, 84 days after receiving the submission on June 4, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3945. Qualitative Detection Of Dengue Virus Antigen In Human Serum Or Plasma Collected From Human Patients With Signs And Symptoms Consistent With Dengue Virus Infection.
| 510(k) Number | K181473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2018 |
| Decision Date | August 27, 2018 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | QCU - Dengue Virus Antigen Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3945 |
| Definition | Qualitative Detection Of Dengue Virus Antigen In Human Serum Or Plasma Collected From Human Patients With Signs And Symptoms Consistent With Dengue Virus Infection |