QTE

Thymidine Kinase Activity

Product code

QTE

Device name

Thymidine Kinase Activity

Device class

Class 2

21 CFR

21 CFR 866.6010

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.

Definition text from the FDA device classification database (U.S. federal government work, public domain).