QTE — Thymidine Kinase Activity Class II
FDA product code QTE covers "Thymidine Kinase Activity", a Class II medical device regulated under 21 CFR 866.6010. 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
- QTE
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202852 | biovica international | DiviTum TKa | July 29, 2022 |