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U.S. Department of Health and Human Services

Product Classification

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Device system, microarray-based, genome-wide, postnatal chromosomal abnormality detection
Definition 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.
Physical State The test system consists of a multiplex qualitative amplification based test system which may utilize different types of microarrays and/or probes to represent the whole genome. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. Should not include devices intended for prenatal use (i.e., diagnostic testing or screening) or for detection of, or screening for, acquired or somatic genetic aberrations (e.g., cancer).
Technical Method The test system uses amplification of extracted genomic DNA followed by hybridization of the amplified, labeled fragments to homologous probes on a microarray. The system uses signal intensities from the bound probes as the basis for determination of copy number variation. Results may also include copy neutral loss of heterozygosity (CNLOH), and detection of mosaicism. The microarray may use different probe sizes and densities across different regions of the genome.
Target Area Human peripheral whole blood or clinical samples
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodePFX
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.5920
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible