Cleared Traditional

CEP 8 SPECTRUMORANGE DNA PROBE KIT

K953591 · Vysis · Pathology

Nov 1996

Decision

486d

Days

Class 2

Risk

About This 510(k) Submission

K953591 is an FDA 510(k) clearance for the CEP 8 SPECTRUMORANGE 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 November 29, 1996, 486 days after receiving the submission on August 1, 1995. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K953591 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 1995
Decision Date	November 29, 1996
Days to Decision	486 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.