# K163367: GenetiSure Dx Postnatal Assay

- Pathway: 510(k) (Traditional)
- Applicant: Agilent Technologies, Inc.
- Decided: Aug 11, 2017 after 254 days
- Product code: PFX (System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection)
- Device class: 2
- Regulation: 21 CFR 866.5920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130018 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130018: Cytoscan (R) DX, Affymetrix, Inc. (2014). Our reading of the summary gave K130313, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130018, Cytoscan (R) DX (Affymetrix, Inc.), granted Jan 17, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Recalls of this device
- Mar 20, 2025 · Class II · Z-1544-2025: DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chro

## Indications for use
GenetiSure Dx Postnatal Assay is a qualitative assay intended for the postnatal detection of copy number variations (CNV) and copy-neutral loss of heterozygosity (cnLOH) in genomic DNA obtained from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. GenetiSure Dx Postnatal Assay is intended for the detection of CNVs and cnLOH associated with developmental delay, intellectual disability, congenital anomalies or dysmorphic features. Assay results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, parental evaluation, clinical genetic evaluation, and counseling, as appropriate. Interpretation of assay results is intended to be performed only by healthcare professionals, board certified in clinical cytogenetics or molecular genetics. The assay is intended to be used on the SureScan Dx Microarray Scanner System and analyzed by CytoDx Software. This device is not intended to be used for standalone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.

Source page: https://510kreport.com/device/K163367
Methodology: https://510kreport.com/methodology