Cleared Traditional

K110215 - CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY

K110215 is an FDA 510(k) clearance for CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RA..., manufactured by Ventana Medical Systems, Inc.. The device is a Class 2 Pathology device with product code MYA cleared through the Traditional 510(k) pathway after a 719-day FDA review.

K110215 · Ventana Medical Systems, Inc. · Pathology device
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Dec 2012
Decision
719d
Days
Class 2
Risk

K110215 is an FDA 510(k) clearance for the CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY. Classified as Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on December 17, 2012 after a review of 719 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K110215

510(k) Number K110215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2010
Decision Date December 17, 2012
Days to Decision 719 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
642d slower than avg
Panel avg: 77d · This submission: 719d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K110215.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
K170028 · Dako Denmark A/S · Dec 2017
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · Leica Biosystems Newcastle, Ltd. · May 2014
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · Dako North America, Inc. · Feb 2013
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · Dako Corp. · Mar 2000
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · Ventana, Inc. · Aug 1999