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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 78d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Pathology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01066507 Completed Observational Industry-sponsored

Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections

Concordance Study for Amplification Detection of Her2 FISH in Breast Tissue Sections

126
Patients (actual)
3
Sites
Condition studied Breast Cancer
Eligibility Female only · 21 Years+
Principal investigator Sheila Dobin, Ph.D.
Sponsor Applied Spectral Imaging Ltd. (industry)
Started 2008-07-01 → Primary completion 2010-01-01
Study completed - no results published. This trial concluded in 2010 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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

All 7
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
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
K080909 · Ikonisys, Inc. · Oct 2008
ARIOL HER-2/NEU FISH
K043519 · Applied Imaging Corp. · Apr 2005
CYTOVISION FOR CEP XY
K042542 · Applied Imaging Corp. · Jan 2005
K101291 · SCANVIEW HER2/NEU FISH SYSTEM
Download PDF FDA Summary Applied Spectral Imag…