Cleared Traditional

K043519 - ARIOL HER-2/NEU FISH

K043519 is an FDA 510(k) clearance for ARIOL HER-2/NEU FISH, manufactured by Applied Imaging Corp.. The device is a Class 2 Pathology device with product code NTH cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K043519 · Applied Imaging Corp. · Pathology device
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Apr 2005
Decision
126d
Days
Class 2
Risk

K043519 is an FDA 510(k) clearance for the ARIOL HER-2/NEU FISH. 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 Imaging Corp. (San Jose, US). The FDA issued a Cleared decision on April 25, 2005 after a review of 126 days - within the typical 510(k) review window.

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 Imaging Corp. devices

FDA 510(k) Submission Details - K043519

510(k) Number K043519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2004
Decision Date April 25, 2005
Days to Decision 126 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 77d · This submission: 126d
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 K043519.
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