DEN140039 is an FDA 510(k) submission for the NOVA View Automated Fluorescense Microscope. This device is classified as a Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use (Class II - Special Controls, product code PIV).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on April 9, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4750. Automated System Consisting Of A Fluorescence Microscope And Software That Acquires, Analyzes, Stores And Displays Digital Images Of Stained Indirect Immunofluorescent Slides. It Is Intended As An Aid In The Detection And Classification Of Certain Antibodies By Indirect Immunofluorescent Technology. A Trained Operator Must Confirm All Device Generated Results..
| 510(k) Number | DEN140039 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 15, 2014 |
| Decision Date | April 09, 2015 |
| Days to Decision | 115 days |
| Submission Type | Post-NSE |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | PIV — Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.4750 |
| Definition | Automated System Consisting Of A Fluorescence Microscope And Software That Acquires, Analyzes, Stores And Displays Digital Images Of Stained Indirect Immunofluorescent Slides. It Is Intended As An Aid In The Detection And Classification Of Certain Antibodies By Indirect Immunofluorescent Technology. A Trained Operator Must Confirm All Device Generated Results. |