System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
FDA product code PFX · Class II (moderate risk) · 21 CFR 866.5920 · 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.
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163367 | GenetiSure Dx Postnatal AssayPFX · Traditional | Agilent Technologies, Inc. | 08/11/2017SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1544-2025 Class II | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female…DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component… | Agilent Technologies, Inc. | 03/20/2025Open, Classified |
| Z-1909-2016 Class III | CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers…During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be… | Affymetrix Inc | 04/14/2016Terminated |