Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
The Fluorescence Polarization Immunoassay for Free Diphenylhydantoin (Phenytoin) is a clinical toxicology in vitro diagnostic device used to measure the free (unbound) fraction of the antiepileptic drug diphenylhydantoin in patient plasma, enabling therapeutic drug monitoring. Classified as FDA Class 2 under 21 CFR 862.3350 in the Clinical Toxicology specialty, it requires 510(k) premarket notification. The product code is MOJ, and it is eligible for third-party 510(k) review.
Basic Information
- Product Code
- MOJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3350
- 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 |
|---|---|---|---|---|
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Mar 30, 2023 | Substantially Equivalent | Roche Diagnostics |
| K952555 | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS | Jul 31, 1995 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K950280 | TDX(R)/TDXFLX(R) FREE PHENYTOIN II | May 02, 1995 | Substantially Equivalent | Abbott Laboratories |
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.