Cleared Traditional

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

K954214 · Vysis · Pathology
Jan 1997
Decision
502d
Days
Class 2
Risk

About This 510(k) Submission

K954214 is an FDA 510(k) clearance for the CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT, a Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment (Class II — Special Controls, product code OXP), submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on January 21, 1997, 502 days after receiving the submission on September 7, 1995. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K954214 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1995
Decision Date January 21, 1997
Days to Decision 502 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code OXP — Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010
Definition X/y Dna Probe Kit Is Intended To Detect Alpha Satellite Sequences In The Centromere Of Chromosome (chr) X And Satellite Iii Dna At Yq12 Of Chr Y Along With Routine Diagnostic Cytogenetic Testing. It Is Indicated For Use As An Adjunct To Standard Cytogenetic Analysis For Identifying And Enumerating Chr X And Y Via Fish In Interphase Nuclei And Metaphase Spreads Obtained From Bone Marrow (bm) Specimens In Recipients Of Opposite-sex Bm Transplantation (bmt) For Hematological Disorders. It Is Not Intended To Be Used As A Stand Alone Assay For Test Reporting; In Subjects With Like-sex Bmt; In Diagnostic Testing Or Screening For Constitutional X And Y Chr Aneuploidies.