System Postnatal Chromosomal Abnormality Detection

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I3CGlobal IVDR, FDA 510k

FDA 510K for System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

A Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection System refers to a laboratory technique that uses a microarray platform to analyze an individual’s entire genome after birth, allowing for the identification of small deletions or duplications on chromosomes that may not be visible with traditional karyotyping, thereby detecting potential genetic abnormalities that could contribute to developmental delays or other medical conditions.

Intended Use of System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

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.

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for FDA 510K for System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
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FDA 510K for Device Code and Regulation Number

Sl.

 No

 Product

Code

 Device Regulation

Number

 Class

1

PFX

 System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

866.5920

2

Anti-Mullerian Hormone Test System (AMH)

Intended Use:

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. Assay is intended for the detection of CNVs and cnLOH associated with developmental delay, intellectual disability, congenital anomalies or dysmorphic features.

Device Description:

System is a microarray-based molecular genetic testing system designed for genome-wide analysis of chromosomal copy number alterations and cnloh in human genomic DNA. The main components and workflow include:

  • Specimen Input and DNA Isolation
  • DNA Labeling and Hybridization
  • Microarray Scanning and Data Acquisition
  • Data Analysis Software

The system is intended to operate as an integrated assay consisting of reagents, microarray slides, scanner instrumentation, and analysis software. The results are qualitative in nature (presence/absence and genomic location of CNVs and cnLOH) and are intended to support clinical interpretation in the context of patient symptoms and other diagnostic finding.

Performance Testing (Analytical) For System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

  • Precision/Reproducibility
  • Linearity/assay reportable range
  • Detection limit
  • Analytical specificity
  • Traceability (controls, calibrators, or method)
  • Analytical Sensitivity
  • Interference
  • Stability
  • Software Verification and Validation

 

Clinical Testing: Required for 510k submission

 

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