Cleared Abbreviated

K060227 - VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (FDA 510(k) Clearance)

Class II Pathology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K060227 · Vision Biosystems, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.