| Device |
human leukocyte antigen (hla) typing companion diagnostic test |
| Regulation Description |
Human leukocyte antigen typing companion diagnostic test. |
| Definition |
A Human Leukocyte Antigen (HLA) Typing Companion Diagnostic (CDx) Test is a prescription genotyping or phenotyping assay intended for use as an aid in identifying patients who have specific HLA allele(s) or express specific HLA antigen(s) and may benefit from treatment with a corresponding therapeutic product, or are likely to be at increased risk for serious adverse reactions as a result of treatment with a corresponding therapeutic product. |
| Physical State |
In vitro test used to detect variants in human genomic DNA, or assay kit containing specific antibodies to detect the corresponding antigens. |
| Technical Method |
Molecular genotyping method used to detect variants in human genomic DNA, or in vitro immunology assay for antigen detection. |
| Target Area |
Human clinical specimens |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Immunology |
|---|
| Product Code | QUK |
|---|
| Premarket Review |
CBER Division
(CBER)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.5960
|
|---|
| 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 |
