Cleared Abbreviated

K013785 - UROVYSION BLADDER CANCER RECURRENCE KIT (FDA 510(k) Clearance)

Class II Immunology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K013785 · Vysis · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 2002
Decision
86d
Days
Class 2
Risk

K013785 is an FDA 510(k) clearance for the UROVYSION BLADDER CANCER RECURRENCE KIT. Classified as System, Test, Tumor Marker, Monitoring, Bladder (product code MMW), Class II - Special Controls.

Submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vysis devices

Submission Details

510(k) Number K013785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2001
Decision Date February 08, 2002
Days to Decision 86 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 104d · This submission: 86d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MMW System, Test, Tumor Marker, Monitoring, Bladder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 Immunology devices follow this clearance model.