Cleared Traditional

K984567 - VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) (FDA 510(k) Clearance)

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

K984567 · Ventana, Inc. · Pathology device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
232d
Days
Class 2
Risk

K984567 is an FDA 510(k) clearance for the VENTANA ER PRIMARY ANTIBODY (CLONE 6F11). Classified as Immunohistochemistry Antibody Assay, Estrogen Receptor (product code MYA), Class II - Special Controls.

Submitted by Ventana, Inc. (Tucson, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 232 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 Ventana, Inc. devices

Submission Details

510(k) Number K984567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date August 12, 1999
Days to Decision 232 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
155d slower than avg
Panel avg: 77d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYA Immunohistochemistry Antibody Assay, Estrogen 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.