Cleared Traditional

K130861 - MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130861 · Dako North America, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
256d
Days
Class 2
Risk

K130861 is an FDA 510(k) clearance for the MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-US.... 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 December 9, 2013 after a review of 256 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dako North America, Inc. devices

Submission Details

510(k) Number K130861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date December 09, 2013
Days to Decision 256 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
179d slower than avg
Panel avg: 77d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.