GenetiSure Dx Postnatal Assay
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- GenetiSure Dx Postnatal Assay EUDAMEDFDA UDI
- Generic Name
- Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- GenetiSure Dx Postnatal Assay EUDAMEDFDA UDI
- Model / Reference
- K1201A EUDAMEDFDA UDI
- Description
- GenetiSure Dx Postnatal Assay FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571108697 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0403P3011C040000N8 EUDAMED
- 510(k) Number
- FDA Product Code
- PFX FDA 510(k)FDA UDI
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
- GMDN Term
- Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.5920 FDA 510(k)
- Regulation Number
- 866.5920 FDA 510(k)FDA UDI
- Market of Registration
- Denmark EUDAMED
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
The GenetiSure Dx Postnatal Assay is a microarray-based, genome-wide system for postnatal chromosomal abnormality detection, classified as a system for molecular karyotyping. It employs array comparative genomic hybridization (aCGH) and single nucleotide polymorphism (SNP) analysis to identify copy-number variations (CNVs) and copy-neutral loss of heterozygosity (cnLOH) in genomic DNA derived from peripheral whole blood samples. This assay supports cytogenetic evaluation of patients with suspected genetic anomalies linked to developmental delay, intellectual disability, congenital anomalies, or dysmorphic features.
The assay is intended for use in clinical laboratory settings and is supplied as a qualitative in vitro diagnostic device. It requires genomic DNA extracted from postnatal whole blood specimens and is designed for single-use per patient sample. The device is authorized under FDA 510(k) clearance and IVDR compliance, with regulatory classification as a Class II medical device (FDA device code: PFX, regulation number: 866.5920). Sterility and storage conditions are specified in the accompanying instructions for use.
Frequently asked questions
What types of genetic abnormalities can the GenetiSure Dx Postnatal Assay detect in patients?
The GenetiSure Dx Postnatal Assay uses array comparative genomic hybridization (aCGH) and single nucleotide polymorphism (SNP) analysis to identify copy-number variations (CNVs) and copy-neutral loss of heterozygosity (cnLOH) in genomic DNA. These analyses help detect chromosomal abnormalities linked to conditions like developmental delay, intellectual disability, congenital anomalies, or dysmorphic features in postnatal patients.
Is the GenetiSure Dx Postnatal Assay designed for single-use or reusable applications?
The assay is explicitly designed for single-use per patient sample, as it is intended to analyze genomic DNA extracted from a specific postnatal whole blood specimen. This ensures accuracy and prevents cross-contamination between patients.
What sample type and preparation is required for the GenetiSure Dx Postnatal Assay?
The assay requires genomic DNA extracted from peripheral whole blood samples collected from postnatal patients. The DNA must be prepared according to the provided instructions for use to ensure compatibility with the microarray-based system.
How is the GenetiSure Dx Postnatal Assay classified under regulatory standards?
The device is classified as a Class II medical device under FDA regulations (device code: PFX, regulation number: 866.5920) and is authorized through FDA 510(k) clearance. It also complies with the In Vitro Diagnostic Regulation (IVDR) in the European Union.
What storage and sterility considerations apply to the GenetiSure Dx Postnatal Assay?
The assay is sterile and its storage conditions are detailed in the accompanying instructions for use. Proper adherence to these guidelines is essential to maintain the integrity and performance of the device, ensuring reliable results for clinical applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GenetiSure Dx Postnatal Assay - Agilent, GenetiSure Dx Postnatal Assay - Agilent, PDF VOL_002_ GenetiSure_Dx_Postnatal_Assay_510k - Section 5 510(k) Summary
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K163367 | Class II | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (3)
- FDA 510(k) K163367 24 fields · synced Sep 18, 2026
- FDA UDI 5d2d9798-ca0c-4e30-9218-3b463db27de0 37 fields · synced May 29, 2026
- EUDAMED 755b9913-ea74-4c50-8b08-9bfe3f6c2b81 61 fields · synced Jul 21, 2026