Infliximab Test System
The infliximab test system (product code QXT) is a Class 2 Clinical Toxicology in vitro diagnostic device (regulation 862.3115) intended for the measurement of infliximab as an aid in the management of patients with Crohn's disease or ulcerative colitis. Requiring 510(k) clearance, it supports therapeutic drug monitoring to guide treatment decisions. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXT
- Device Class
- FDA class 2
- Regulation Number
- 862.3115
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohns disease or ulcerative colitis.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN210056 | Procise IFX | Sep 29, 2023 | Unknown | Procisedx, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.