510(k) K131140
K131140 is an FDA 510(k) premarket notification submitted by Omnyx, LLC for the device "OMNYX IDP FOR HER2 MANUAL APPLICATION". The FDA issued a decision of Substantially Equivalent on April 1, 2014. The device falls under product code OEO (Automated Digital Image Manual Interpretation Microscope), a Class II device regulated under 21 CFR 864.1860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2014
- Date Received
- April 22, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Digital Image Manual Interpretation Microscope
- Device Class
- Class II
- Regulation Number
- 864.1860
- Review Panel
- PA
- Submission Type
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.