ONLINE TDM Phenytoin - Free Phenytoin application
Device Facts
| Record ID | K230161 |
|---|---|
| Device Name | ONLINE TDM Phenytoin - Free Phenytoin application |
| Applicant | Roche Diagnostics |
| Product Code | MOJ · Clinical Toxicology |
| Decision Date | Mar 30, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3350 |
| Device Class | Class 2 |
Indications for Use
ONLINE TDM Phenytoin - Free Phenytoin application is an in vitro test for the quantitative determination of free phenytoin in human serum and plasma on cobas c systems. The determination of free phenytoin is used in monitoring levels of free phenytoin to ensure appropriate therapy.
Device Story
Device is an in vitro diagnostic test for quantitative determination of free phenytoin in human serum and plasma. Sample processing requires ultrafiltration to remove bound phenytoin prior to measurement. Principle of operation is Kinetic Interaction of Microparticles in a Solution (KIMS); phenytoin antibody is covalently coupled to microparticles; drug derivative linked to macromolecule. Competitive reaction occurs between drug conjugate and phenytoin in sample for binding to antibody on microparticles; resulting turbidity is photometrically detected and inversely proportional to drug concentration. Used in clinical laboratories on cobas c systems. Healthcare providers use output to monitor free phenytoin levels for therapeutic management. Benefits include accurate quantification of free drug fraction to guide clinical dosing decisions.
Clinical Evidence
Bench testing only. Performance evaluated on cobas c 503 analyzer. Precision (repeatability/intermediate) met acceptance criteria (CVs 2.1-3.5%). Linearity confirmed for 0.400-4.00 µg/mL. Method comparison against COBAS INTEGRA 400 plus (n=138) showed strong correlation (Passing/Bablok slope 1.035, r=0.998). Interference studies evaluated endogenous substances and exogenous drugs; cross-reactivity and matrix effects (serum, Li-Heparin, K2-EDTA, K3-EDTA) met acceptance criteria.
Technological Characteristics
In vitro diagnostic assay using KIMS (Kinetic Interaction of Microparticles in a Solution). Reagents: R1 (phenytoin conjugate, PIPES buffer) and R2 (anti-phenytoin antibody, latex microparticles). Measuring range: 0.400-4.00 µg/mL. Instrumentation: cobas c systems (e.g., cobas c 503). Sample type: serum and plasma (Li-Heparin, K2-EDTA, K3-EDTA). Requires pre-analytical ultrafiltration.
Indications for Use
Indicated for quantitative determination of free phenytoin in human serum and plasma for therapeutic drug monitoring to ensure appropriate therapy.
Regulatory Classification
Identification
A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.
Related Devices
- K030428 — ROCHE ONLINE TDM PHENYTOIN · Roche Diagnostics Corp. · Apr 28, 2003
- K993026 — ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS · Syva Co. · Jan 27, 2000
- K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS · Thermo Electron OY · Oct 17, 2007
- K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 · Roche Diagnostics Corp. · Sep 12, 2007
