FDA product code PFX: System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
PFX is the FDA product code for system, microarray-based, genome-wide, postnatal chromosomal abnormality detection. It is a Class II device, regulated under 21 CFR 866.5920 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under PFX. The average 510(k) review took 254 days (median 254). 1 De Novo request was granted under it. FDA has posted 2 recalls for PFX devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection |
| Device class | Class II |
| Regulation | 21 CFR 866.5920 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for PFX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 254 |
Top PFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Agilent Technologies, Inc. | 1 | 2017-08-11 |
Most recent PFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163367 | Agilent Technologies, Inc. | GenetiSure Dx Postnatal Assay | 2017-08-11 | 254 |
Recalls for PFX devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-03-20.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code PFX?
PFX is the FDA product code for system, microarray-based, genome-wide, postnatal chromosomal abnormality detection. It is a Class II device, regulated under 21 CFR 866.5920 and reviewed by the Pathology panel.
What device class is PFX?
Class II, regulation 21 CFR 866.5920. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFX?
Across 1 cleared submissions the average was 254 days from receipt to decision (median 254).
Which companies have the most PFX clearances?
Agilent Technologies, Inc. (1).
Have PFX devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code PFX
- Run a recall and safety report across every PFX manufacturer
- Watch product code PFX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.