QSA — Circulating Tumor Cell (Ctc) Enrichment Device Class II
FDA product code QSA covers "Circulating Tumor Cell (Ctc) Enrichment Device", a Class II medical device regulated under 21 CFR 866.6110. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QSA
- Device Class
- Class II
- Regulation Number
- 866.6110
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200062 | angle europe | Parsortix PC1 Device | May 24, 2022 |