| Device |
circulating tumor cell (ctc) enrichment device |
| Definition |
A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing. |
| Physical State |
The device includes single-use cassettes for the size-based CTC retention and an automated fluidic handling system. |
| Technical Method |
Capturing and harvesting rare cells (e.g. CTCs) from blood is based on cell size and deformability (i.e. compressibility). The isolation/capture mechanism is a purely physical method rather than a chemical or biological one, and therefore epitope independent and consequently agnostic to cellular phenotype. |
| Target Area |
Metastatic cancer patient blood for enrichment of CTCs for subsequent analysis. |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Pathology |
|---|
| Product Code | QSA |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6110
|
|---|
| 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 |
