Cleared Traditional

K080909 - ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (FDA 510(k) Clearance)

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

K080909 · Ikonisys, Inc. · Pathology device
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Oct 2008
Decision
199d
Days
Class 2
Risk

K080909 is an FDA 510(k) clearance for the ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000. Classified as System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (product code NTH), Class II - Special Controls.

Submitted by Ikonisys, Inc. (New Haven, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 199 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.4700 - 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 Ikonisys, Inc. devices

Submission Details

510(k) Number K080909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date October 17, 2008
Days to Decision 199 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
122d slower than avg
Panel avg: 77d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4700
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.