Clozapine Test System
The Clozapine Test System is a Class 2 clinical chemistry device intended for the in vitro quantitative measurement of clozapine in human specimens, used for therapeutic drug monitoring of patients receiving clozapine, an antipsychotic medication requiring careful monitoring due to its risk of agranulocytosis. It requires 510(k) clearance and is regulated under 21 CFR 862.3245, reviewed by the Toxicology panel within the Clinical Chemistry medical specialty. The product code is QKT. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QKT
- Device Class
- FDA class 2
- Regulation Number
- 862.3245
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.
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 |
|---|---|---|---|---|
| DEN190028 | MyCare Psychiatry Clozapine Assay Kit | Apr 16, 2020 | Unknown | Saladax Biomedical, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.