510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PFXClass II

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

21 CFR 866.5920 / Immunology
FDA source (opens on fda.gov)

PFX is the FDA product code for System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection, a class II device type, regulated under 21 CFR 866.5920. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PFX
Device name
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
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.
Regulation
21 CFR 866.5920
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
2

Clearances, product code PFX

By decision year
2 clearances under product code PFX with a decision year between 2014 and 2017, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFX by decision year
YearClearances
20141
20171

Applicants with the most clearances

Product code PFX
Applicants holding the most 510(k) clearances under product code PFX
ApplicantClearances
Affymetrix Inc1
Agilent Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code