| Device |
dna-probe kit, human chromosome x and y, bmt engraftment |
| Regulation Description |
Tumor-associated antigen immunological test system. |
| Definition |
X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies. |
| Physical State |
Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders |
| Technical Method |
fluorescence in situ hybridization (FISH) |
| Target Area |
opposite-sex bone marrow transplantation for hematological disorders |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Pathology |
|---|
| Product Code | OXP |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6010
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
