Cleared Traditional

K010288 - ANEUVYSION MULITICOLOR DNA PROBE KIT (FDA 510(k) Clearance)

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

K010288 · Vysis · Pathology device
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Optimized for regulatory review, auditing and printing
Apr 2001
Decision
72d
Days
Class 2
Risk

K010288 is an FDA 510(k) clearance for the ANEUVYSION MULITICOLOR DNA PROBE KIT. Classified as Dna-probe Kit, Human Chromosome (product code OYU), Class II - Special Controls.

Submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on April 13, 2001 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vysis devices

Submission Details

510(k) Number K010288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date April 13, 2001
Days to Decision 72 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
5d faster than avg
Panel avg: 77d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OYU Dna-probe Kit, Human Chromosome
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4700
Definition Detection Of Alpha Satellite Sequences In The Centromere Regions Of Human Chromosomes In Conjunction With Routine Diagnostic Cytgenetic Testing. It Is Indicated For Use As An Adjunct To Standard Cytogenetic Methaphase Analysis A Identifying And Enumerating Human Chromosomes Via Fluorescence In Situ Hybridization (fish) In Metaphase Cells And Interphase Nuclei Of Human Cells. It Is Not Intended To Be Used As A Stand Alone Assay For Test Reporting Or Clinical Diagnosis. Fish Results Are Intended To Be Reported And Interpreted Only In Conjunction With Results Of Standard Cytogenetic Analysis, Performed Concurrently, Utilizing The Same Patient Specimen.
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.