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 |
Center for Biologics Evaluation and Research Branch
(CBER)
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 |