Cleared Special

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody (K183102) - FDA 510(k) Clearance

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

K183102 · Leica Biosystems Newcastle, Limited · Pathology device
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Dec 2018
Decision
30d
Days
Class 2
Risk

K183102 is an FDA 510(k) clearance for the BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocas.... Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), 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.

View all Leica Biosystems Newcastle, Limited devices

Submission Details

510(k) Number K183102 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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 77d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Leica Biosystems, Inc.
Zhijun Julie Pan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.