PFX

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

Product code

PFX

Device name

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

Device class

Class 2

21 CFR

21 CFR 866.5920

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).