FDA product code QTE: Thymidine Kinase Activity
QTE is the FDA product code for thymidine kinase activity. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under QTE, 1 in the last five years. The average 510(k) review took 669 days (median 669).
Definition
In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
Classification
| Field | Value |
|---|---|
| Device name | Thymidine Kinase Activity |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for QTE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 669 |
Compare with all 510(k) review times · Search every QTE clearance
Top QTE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biovica International AB | 1 | 2022-07-29 |
Most recent QTE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202852 | Biovica International AB | DiviTum TKa | 2022-07-29 | 669 |
Recalls for QTE devices
openFDA lists no recalls for product code QTE.
Frequently asked questions
What is FDA product code QTE?
QTE is the FDA product code for thymidine kinase activity. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is QTE?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code QTE?
Across 1 cleared submissions the average was 669 days from receipt to decision (median 669).
Which companies have the most QTE clearances?
Biovica International AB (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QTE
- Run a recall and safety report across every QTE manufacturer
- Watch product code QTE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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