Cleared Traditional

OMNYX IDP FOR HER2 MANUAL APPLICATION

K131140 · Omnyx, LLC · Pathology

Apr 2014

Decision

344d

Days

Class 2

Risk

About This 510(k) Submission

K131140 is an FDA 510(k) clearance for the OMNYX IDP FOR HER2 MANUAL APPLICATION, a Automated Digital Image Manual Interpretation Microscope (Class II — Special Controls, product code OEO), submitted by Omnyx, LLC (Marlborough, US). The FDA issued a Cleared decision on April 1, 2014, 344 days after receiving the submission on April 22, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K131140 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2013
Decision Date	April 01, 2014
Days to Decision	344 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	OEO — Automated Digital Image Manual Interpretation Microscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1860
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.