Device |
fluorescence in situ hybridization, chromosome 17p deletion (tp53) |
Definition |
A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL). |
Physical State |
Probe Kit consists of slide preparation materials, fluorescent FISH probes, buffers and nuclear counterstain, followed by manual signal enumeration using a fluorescence-enabled microscope. |
Technical Method |
The assay uses fluorescence in situ hybridization to identify a deletion in chromosome 17 at the TP53 gene locus in peripheral blood from CLL Patients. |
Target Area |
Peripheral blood |
Review Panel |
Molecular Genetics |
Product Code | PNK |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
Submission Type |
PMA
|
Device Class |
3
|
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 |