Cleared Traditional

K101291 - SCANVIEW HER2/NEU FISH SYSTEM

K101291 is an FDA 510(k) clearance for SCANVIEW HER2/NEU FISH SYSTEM, manufactured by Applied Spectral Imaging , Ltd.. The device is a Class 2 Pathology device with product code NTH cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K101291 · Applied Spectral Imaging , Ltd. · Pathology device
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Nov 2010
Decision
200d
Days
Class 2
Risk

K101291 is an FDA 510(k) clearance for the SCANVIEW HER2/NEU FISH SYSTEM. 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 Applied Spectral Imaging , Ltd. (Haifa, IL). The FDA issued a Cleared decision on November 23, 2010 after a review of 200 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 Applied Spectral Imaging , Ltd. devices

FDA 510(k) Submission Details - K101291

510(k) Number K101291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2010
Decision Date November 23, 2010
Days to Decision 200 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
123d slower than avg
Panel avg: 77d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NTH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays

Devices cleared under the same product code (NTH) and FDA review panel - the closest regulatory comparables to K101291.
DUET SYSTEM
K130775 · Bioview , Ltd. · May 2014
GENASIS SCANVIEW SYSTEM
K122554 · Applied Spectral Imaging , Ltd. · Feb 2013
SCANVIEW SYSTEM
K110345 · Applied Spectral Imaging · Oct 2011
ARIOL HER-2/NEU FISH
K043519 · Applied Imaging Corp. · Apr 2005
CYTOVISION FOR CEP XY
K042542 · Applied Imaging Corp. · Jan 2005