Cleared Traditional

ANEUVYSION MULITICOLOR DNA PROBE KIT

K010288 · Vysis · Pathology
Apr 2001
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K010288 is an FDA 510(k) clearance for the ANEUVYSION MULITICOLOR DNA PROBE KIT, a Dna-probe Kit, Human Chromosome (Class II — Special Controls, product code OYU), submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on April 13, 2001, 72 days after receiving the submission on January 31, 2001. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number K010288 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code OYU — Dna-probe Kit, Human Chromosome
Device Class Class II — 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.