Circulating Tumor Cell (Ctc) Enrichment Device
The Circulating Tumor Cell (CTC) Enrichment Device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of cancer patients, enabling subsequent downstream diagnostic testing and analysis of tumor cell characteristics. It serves as a preparatory step in liquid biopsy workflows. Classified as FDA Class 2 under regulation 866.6110, it requires 510(k) clearance and falls under the Immunology specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QSA
- Device Class
- FDA class 2
- Regulation Number
- 866.6110
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200062 | Parsortix PC1 Device | May 24, 2022 | Unknown | Angle Europe , Ltd. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.