Cleared Abbreviated

K060227 - VISION BIOSYSTEMS ESTROGEN RECEPTOR CLO...

K060227 is an FDA 510(k) clearance for VISION BIOSYSTEMS ESTROGEN RECEPTOR CLO..., manufactured by Vision Biosystems, Inc.. The device is a Class 2 Pathology device with product code MYA cleared through the Abbreviated 510(k) pathway after a 115-day FDA review.

K060227 · Vision Biosystems, Inc. · Pathology device
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May 2006
Decision
115d
Days
Class 2
Risk

K060227 is an FDA 510(k) clearance for the VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11). Classified as Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA), Class II - Special Controls.

Submitted by Vision Biosystems, Inc. (Norwell, US). The FDA issued a Cleared decision on May 25, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vision Biosystems, Inc. devices

FDA 510(k) Submission Details - K060227

510(k) Number K060227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2006
Decision Date May 25, 2006
Days to Decision 115 days
Submission Type Abbreviated
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 77d · This submission: 115d
Pathway characteristics
Standards-based clearance path.

MYA Device Classification - Class 2, Special Controls

Product Code MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
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.

Regulatory Peers - MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

Devices cleared under the same product code (MYA) and FDA review panel - the closest regulatory comparables to K060227.
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
K183100 · Leica Biosystems Newcastle, Limited · Dec 2018
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · Ventana Medical Systems, Inc. · Dec 2012
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · Dako Corp. · Mar 2000