Fluorescence Polarization Immunoassay, Carbamazepine
A fluorescence polarization immunoassay for carbamazepine is a laboratory test that uses polarized fluorescent light measurement to quantify carbamazepine, an anticonvulsant and mood-stabilizing drug, in patient specimens for therapeutic drug monitoring during treatment of epilepsy and bipolar disorder. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LGI and is regulated under 21 CFR 862.3645 within the Clinical Toxicology specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- LGI
- Device Class
- FDA class 2
- Regulation Number
- 862.3645
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944063 | FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE | Nov 10, 1994 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K940682 | AXSYM(TM) QUINIDINE | Jun 21, 1994 | Substantially Equivalent | ABBOTT LABORATORIES |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent | INNOTRON OF OREGON, INC. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.