Cleared Traditional

K122556 - VISION BIOSYSTEMS ESTROGEN RECEPTOR CLO...

K122556 is an FDA 510(k) clearance for VISION BIOSYSTEMS ESTROGEN RECEPTOR CLO..., manufactured by Leica Biosystems Newcastle, Ltd.. The device is a Class 2 Pathology device with product code MYA cleared through the Traditional 510(k) pathway after a 635-day FDA review.

K122556 · Leica Biosystems Newcastle, Ltd. · Pathology device
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May 2014
Decision
635d
Days
Class 2
Risk

K122556 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 Leica Biosystems Newcastle, Ltd. (Richmond, US). The FDA issued a Cleared decision on May 19, 2014 after a review of 635 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 Leica Biosystems Newcastle, Ltd. devices

FDA 510(k) Submission Details - K122556

510(k) Number K122556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date May 19, 2014
Days to Decision 635 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
558d slower than avg
Panel avg: 77d · This submission: 635d
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 K122556.
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