| Device |
direct-to-consumer access pharmacogenetic assessment system |
| Definition |
A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users. |
| Physical State |
The test system includes reagents and instrumentation for measuring and analyzing nucleic acid sequences and methods for interpretation of the pharmacogenetic associations for detected nucleic acid sequence variations. The test system provides information on the pharmacogenetic associates for the detected variants in lay-user reports. |
| Technical Method |
Measures and analyzes nucleic acid sequences and interprets pharmacogenetic associations for detected nucleic acid sequence variations. |
| Target Area |
Sample collection device, molecular diagnostic test |
| Regulation Medical Specialty |
Molecular Genetics |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | QDJ |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.3364
|
|---|
| 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 |
