Cleared Abbreviated

K062615 - VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16

K062615 is an FDA 510(k) clearance for VISION BIOSYSTEMS PROGESTERONE RECEPTOR..., manufactured by Vision Biosystems, Inc.. The device is a Class 2 Pathology device with product code MXZ cleared through the Abbreviated 510(k) pathway after a 146-day FDA review.

K062615 · Vision Biosystems, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
146d
Days
Class 2
Risk

K062615 is an FDA 510(k) clearance for the VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16. Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Vision Biosystems, Inc. (Ventura, US). The FDA issued a Cleared decision on January 29, 2007 after a review of 146 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 - K062615

510(k) Number K062615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date January 29, 2007
Days to Decision 146 days
Submission Type Abbreviated
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 78d · This submission: 146d
Pathway characteristics
Standards-based clearance path.

MXZ Device Classification - Class 2, Special Controls

Product Code MXZ Immunohistochemistry Assay, Antibody, Progesterone 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 - MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

All 12
Devices cleared under the same product code (MXZ) and FDA review panel - the closest regulatory comparables to K062615.
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)
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MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
K130861 · Dako North America, Inc. · Dec 2013
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
K103818 · Ventana Medical Sytems, Inc. · Nov 2011
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)
K060462 · Lab Vision Corp. · Apr 2006
DAKOCYTOMATION ER/PR PHARMDX KIT
K042884 · Dakocytomation California, Inc. · Feb 2005
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960 · Biogenex Laboratories · Mar 2002