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U.S. Department of Health and Human Services

Product Classification

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Device automated digital image manual interpretation microscope
Regulation Description Immunohistochemistry reagents and kits.
Definition 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.
Physical State 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
Target Area Immunohistochemical stained microscope slides
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeOEO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.1860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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