Cleared Special

K183100 - Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra (FDA 510(k) Clearance)

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

K183100 · Leica Biosystems Newcastle, Limited · Pathology device
Dec 2018
Decision
30d
Days
Class 2
Risk

K183100 is an FDA 510(k) clearance for the Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen.... Classified as Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA), Class II - Special Controls.

Submitted by Leica Biosystems Newcastle, Limited (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on December 7, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K183100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2018
Decision Date December 07, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Pathology (PA)
Summary Statement
Regulatory Context
Review time vs. panel average
193d faster than avg
Panel avg: 223d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.