Cleared Traditional

K131140 - OMNYX IDP FOR HER2 MANUAL APPLICATION (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131140 · Omnyx, LLC · Pathology device
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Apr 2014
Decision
344d
Days
Class 2
Risk

K131140 is an FDA 510(k) clearance for the OMNYX IDP FOR HER2 MANUAL APPLICATION. Classified as Automated Digital Image Manual Interpretation Microscope (product code OEO), Class II - Special Controls.

Submitted by Omnyx, LLC (Marlborough, US). The FDA issued a Cleared decision on April 1, 2014 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K131140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 77d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEO Automated Digital Image Manual Interpretation Microscope
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.