K161951 is an FDA 510(k) clearance 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 Cleared decision on July 22, 2016, 7 days after receiving the submission on July 15, 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 | K161951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2016 |
| Decision Date | July 22, 2016 |
| Days to Decision | 7 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| 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. |