Cleared Traditional

GenetiSure Dx Postnatal Assay

K163367 · Agilent Technologies, Inc. · Medical Genetics
Aug 2017
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K163367 is an FDA 510(k) clearance for the GenetiSure Dx Postnatal Assay, a System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection (Class II — Special Controls, product code PFX), submitted by Agilent Technologies, Inc. (Carpinteria, US). The FDA issued a Cleared decision on August 11, 2017, 254 days after receiving the submission on November 30, 2016. This device falls under the Medical Genetics review panel. Regulated under 21 CFR 866.5920.

Submission Details

510(k) Number K163367 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2016
Decision Date August 11, 2017
Days to Decision 254 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF

Device Classification

Product Code PFX — System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5920
Definition A Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection System Is Used To Qualitatively Detect Constitutional Gains And Losses In Chromosomal Copy Numbers Across The Human Genome Using Microarray Methods. It Is Intended As An Aid In The Postnatal Diagnosis Of Developmental Delay And/or Intellectual Disability (dd/id), Congenital Anomalies, And Dysmorphic Features In Conjunction With Other Clinical Information Currently Used In Postnatal Diagnosis. It Is Not Intended To Be Used For Standalone Diagnostic Purposes, Prenatal Or Pre-implantation Testing Or Screening, Population Screening, Or For The Detection Of, Or Screening For, Acquired Or Somatic Genetic Aberrations.