Cleared Traditional

K103818 - CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY

K103818 is an FDA 510(k) clearance for CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2..., manufactured by Ventana Medical Sytems, Inc.. The device is a Class 2 Pathology device with product code MXZ cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K103818 · Ventana Medical Sytems, Inc. · Pathology device
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Nov 2011
Decision
322d
Days
Class 2
Risk

K103818 is an FDA 510(k) clearance for the CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY. Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Ventana Medical Sytems, Inc. (Tucson, US). The FDA issued a Cleared decision on November 16, 2011 after a review of 322 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.

View all Ventana Medical Sytems, Inc. devices

FDA 510(k) Submission Details - K103818

510(k) Number K103818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2010
Decision Date November 16, 2011
Days to Decision 322 days
Submission Type Traditional
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
244d slower than avg
Panel avg: 78d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K103818.
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
K171753 · Leica Biosystems Newcastle, Limited · Jul 2017
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)
K160922 · Dako North America, Inc. · May 2016
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
K130861 · Dako North America, Inc. · Dec 2013
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
K062615 · Vision Biosystems, Inc. · Jan 2007
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