K153150 is an FDA 510(k) clearance for the AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000. 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 Cleared decision on November 24, 2015, 22 days after receiving the submission on November 2, 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 | K153150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2015 |
| Decision Date | November 24, 2015 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| 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. |