| Device |
autosomal recessive carrier screening gene mutation detection system |
| Definition |
Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing. |
| Physical State |
Multiplex microarray based detection system |
| Technical Method |
Microarray based method to detect genomic DNA mutations |
| Target Area |
human clinical specimens |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Pathology |
|---|
| Product Code | PKB |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.5940
|
|---|
| 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 |
