| Device |
hiv-1 genotyping assay using ngs technology |
| Regulation Description |
Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology. |
| Definition |
The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection. |
| Physical State |
Automated instrument, liquid handling, software interfaces, software, primers, reagents, buffers, bioinformatics pipeline, genomic databases |
| Technical Method |
Nucleic acid extraction, amplification, next generation sequencing, bioinformatics, alignment, results interpretation |
| Target Area |
Whole blood, plasma |
| Regulation Medical Specialty |
Molecular Genetics |
| Review Panel |
Microbiology |
|---|
| Product Code | QIC |
|---|
| Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3955
|
|---|
| 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 |
|
|
