DeviceClearance

Product code QTE— Immunology

DiviTum TKa

Classification name
Thymidine Kinase Activity
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QTE under 21 CFR 866.6010, via openFDA

Market context for product code QTE

FDA has cleared 1 device under product code QTE, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QTE

Recent clearances under product code QTE

Data sourced from openFDA. This site is unofficial and independent of the FDA.