| 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 Code | QNC |
|---|
| 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 |
