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U.S. Department of Health and Human Services

Product Classification

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Device whole exome sequencing constituent device
Definition A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.
Physical State Consists of reagents, instrumentation, software and instructions.
Technical Method Uses high throughput, massive parallel exon sequencing including molecular reagents for library preparation, sequencing, target enrichment, sequencing instrumentation and bioinformatics software. May also include collection device and software for generating user defined test reports.
Target Area Human specimens
Regulation Medical Specialty Molecular Genetics
Review Panel Pathology
Product CodeQNC
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.6000
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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