510(k) · Cleared
Recalled · Class II · 2025GenetiSure Dx Postnatal Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies, Inc. · PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
Cleared on Aug 11, 2017 as substantially equivalent to DEN130018 (Affymetrix, Inc., 2014) after a 254-day review. Its family tree reaches back 1 generation to 2014. It has been recalled once.
- Decided
- Aug 11, 2017
- Review
- 254 days
- Class
- Class II
- Product code
- PFX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130018 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130018 Cytoscan (R) DXAffymetrix, Inc. · 2014
- This deviceK163367 GenetiSure Dx Postnatal AssayAgilent Technologies, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130018 | Cytoscan (R) DX | Affymetrix, Inc. | 2014 | — |
| 0 (this device) | K163367 | GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | 2017 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN130018 | Cytoscan (R) DX 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. | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2025 | Class II | Z-1544-2025 | Nonconforming Material/Component | 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 Chromosome 12 baseline shift, which may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PFX devicesPFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PFX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PFX
Too few PFX 510(k)s in any year since 2007 to give a median.
Recalls per year · PFX
No recall names PFX since 2007.
Adverse event reports per year · PFX
2in 2025
MAUDE reports naming product code PFX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (174 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163367: GenetiSure Dx Postnatal Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163367
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026