Cleared Traditional

K020023 - DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING

K020023 is an FDA 510(k) clearance for DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGES..., manufactured by Dako Corp.. The device is a Class 2 Pathology device with product code MXZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K020023 · Dako Corp. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
56d
Days
Class 2
Risk

K020023 is an FDA 510(k) clearance for the DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBO.... Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dako Corp. devices

FDA 510(k) Submission Details - K020023

510(k) Number K020023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2002
Decision Date February 28, 2002
Days to Decision 56 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 77d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXZ Device Classification - Class 2, Special Controls

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 Peers - MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

All 9
Devices cleared under the same product code (MXZ) and FDA review panel - the closest regulatory comparables to K020023.
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
K130861 · Dako North America, Inc. · Dec 2013
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
K103818 · Ventana Medical Sytems, Inc. · Nov 2011
DAKOCYTOMATION ER/PR PHARMDX KIT
K042884 · Dakocytomation California, Inc. · Feb 2005
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · Ventana Medical Systems, Inc. · Jul 1999