Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)
Device Code: 3145
Product Code(s):
PNK 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).
Device Classification Information
| Device Type ID | 3145 |
| Device Name | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53) |
| 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 |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PNK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3145 |
| Device | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53) |
| Product Code | PNK |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 20:24:33