Cleared Special

K160922 - FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link) (FDA 510(k) Clearance)

Also includes:
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

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

K160922 · Dako North America, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
29d
Days
Class 2
Risk

K160922 is an FDA 510(k) clearance for the FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-U.... Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Dako North America, Inc. (Carpinteria, US). The FDA issued a Cleared decision on May 3, 2016 after a review of 29 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 Dako North America, Inc. devices

Submission Details

510(k) Number K160922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2016
Decision Date May 03, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 77d · This submission: 29d
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.