Cleared Traditional

K130775 - DUET SYSTEM (FDA 510(k) Clearance)

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

K130775 · Bioview , Ltd. · Pathology device
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May 2014
Decision
415d
Days
Class 2
Risk

K130775 is an FDA 510(k) clearance for the DUET 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 Bioview , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on May 9, 2014 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

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Submission Details

510(k) Number K130775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2013
Decision Date May 09, 2014
Days to Decision 415 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
338d slower than avg
Panel avg: 77d · This submission: 415d
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.