FDA 510k for Automated Digital Image Manual Interpretation Microscope
The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer.
Intended Use of Automated Digital Image Manual Interpretation Microscope
It provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Automated Digital Image Manual Interpretation Microscope
Automated Digital Image Manual Interpretation Microscope Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | OEO | automated digital image manual interpretation microscope | Immunohistochemistry reagents and kits. | 864.1860 | 2 |
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Device Description of Automated Digital Image Manual Interpretation Microscope
Physical state of automated digital microscope slide scanner, computer, color monitor, keyboard and digital pathology information management software Technical Method:
Digital microscopy image of stained tissue on a microscope slide, used to determine HER2 IHC status.
It is a prescription-use device only.
It is an instrument-plus-software system designed to assist the qualified pathologist in the consistent assessment of protein expression in immunohistochemically stained histologic sections from formalin-fixed, paraffin-embedded normal and neoplastic tissues. The system consists of a software and Hardware i.e, slide scanner, computer, monitor, keyboard, and mouse for specific immunohistochemical markers, and software with a Windows web browser-based user interface.
It is a web-based, end-to-end, digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of pathology specimens. Using the software, pathologists can view digital images, add annotations and generate reports.
Performance Testing (Analytical)
- Precision/Reproducibility
- Detection studies
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Required for 510k submission and IVDR CE Marking