Cleared Traditional

K140957 - GENASIS HIPATH IHC FAMILY (FDA 510(k) Clearance)

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

K140957 · Applied Spectral Imaging , Ltd. · Pathology device
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Jan 2015
Decision
276d
Days
Class 2
Risk

K140957 is an FDA 510(k) clearance for the GENASIS HIPATH IHC FAMILY. Classified as Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (product code NQN), Class II - Special Controls.

Submitted by Applied Spectral Imaging , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on January 15, 2015 after a review of 276 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 Applied Spectral Imaging , Ltd. devices

Submission Details

510(k) Number K140957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date January 15, 2015
Days to Decision 276 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
199d slower than avg
Panel avg: 77d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
Definition Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.
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.