Product code PFX— Immunology

“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.”

FDA has cleared 2 devices under product code PFX between 2014 and 2017, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20171 clearance
• 20141 clearance

• Agilent Technologies, Inc.1 clearance
• Affymetrix, Inc.1 clearance

• K163367 — GenetiSure Dx Postnatal AssayAgilent Technologies, Inc.·2017-08-11
• DEN130018 — CYTOSCAN(R) DXAffymetrix, Inc.·2014-01-17