DEN150030 is an FDA 510(k) submission for the KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay. This device is classified as a Aquaporin-4 Autoantibody (Class II - Special Controls, product code PNI).
Submitted by Kronus, Inc. (Star, US). The FDA issued a Not Cleared (DENG) decision on April 25, 2016.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5665. For The Determination Of Autoantibodies To Aquaporin-4 In Human Serum And Plasma. The Test May Be Useful As An Aid In The Diagnosis Of Neuromyelitis Optica (nmo) And Neuromyelitis Optica Spectrum Disorders (nmosd). The Test Is Not To Be Used Alone And Is To Be Used In Conjunction With Other Clinical And Radiological (mri) Laboratory Findings..
| 510(k) Number | DEN150030 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 02, 2015 |
| Decision Date | April 25, 2016 |
| Days to Decision | 298 days |
| Submission Type | Direct |
| Review Panel | Immunology (IM) |
| Summary | - |
| Product Code | PNI - Aquaporin-4 Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5665 |
| Definition | For The Determination Of Autoantibodies To Aquaporin-4 In Human Serum And Plasma. The Test May Be Useful As An Aid In The Diagnosis Of Neuromyelitis Optica (nmo) And Neuromyelitis Optica Spectrum Disorders (nmosd). The Test Is Not To Be Used Alone And Is To Be Used In Conjunction With Other Clinical And Radiological (mri) Laboratory Findings. |