PFX

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5920

Medical specialty

Immunology

FDA 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.

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