Cleared Traditional

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) (K990618) - FDA 510(k) Clearance

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

K990618 · Ventana Medical Systems, Inc. · Pathology device
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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

Submission Details

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
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.

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.

Regulatory Peers - MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

All 12
Devices cleared under the same product code (MXZ) and FDA review panel - the closest regulatory comparables to K990618.
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
K193393 · Leica Biosystems Newcastle, Ltd. · Mar 2020
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
K183102 · Leica Biosystems Newcastle, Limited · Dec 2018