Cleared Traditional

K042884 - DAKOCYTOMATION ER/PR PHARMDX KIT

K042884 is an FDA 510(k) clearance for DAKOCYTOMATION ER/PR PHARMDX KIT, manufactured by Dakocytomation California, Inc.. The device is a Class 2 Pathology device with product code MXZ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K042884 · Dakocytomation California, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
119d
Days
Class 2
Risk

K042884 is an FDA 510(k) clearance for the DAKOCYTOMATION ER/PR PHARMDX KIT. Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Dakocytomation California, Inc. (Carpinteria, US). The FDA issued a Cleared decision on February 15, 2005 after a review of 119 days - within the typical 510(k) review window.

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 Dakocytomation California, Inc. devices

FDA 510(k) Submission Details - K042884

510(k) Number K042884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2004
Decision Date February 15, 2005
Days to Decision 119 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
42d slower than avg
Panel avg: 77d · This submission: 119d
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 K042884.
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DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K020023 · Dako Corp. · Feb 2002
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · Ventana Medical Systems, Inc. · Jul 1999