Cleared Traditional

K990618 - VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)

K990618 is an FDA 510(k) clearance for VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6), manufactured by Ventana Medical Systems, Inc.. The device is a Class 2 Pathology device with product code MXZ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K990618 · Ventana Medical Systems, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
148d
Days
Class 2
Risk

K990618 is an FDA 510(k) clearance for the VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6). Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on July 23, 1999 after a review of 148 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 Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K990618

510(k) Number K990618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1999
Decision Date July 23, 1999
Days to Decision 148 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
71d slower than avg
Panel avg: 77d · This submission: 148d
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 K990618.
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
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K020023 · Dako Corp. · Feb 2002