Du Pont Phenytoin Assay and Calibrator

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K863888 ↗

FDA Product Code

DIR

Device Class

Class II

Regulation

21 CFR Part 862.3250

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from E.I. Dupont DE Nemours & Co., Inc. →

• What clinical area is this phenytoin assay primarily used for, and how does it help patients?

  This assay is designed for clinical toxicology, specifically to measure phenytoin concentrations in biological samples like blood or serum. It aids in monitoring therapeutic drug levels to ensure patients remain within safe and effective dosage ranges, reducing the risk of toxicity or subtherapeutic outcomes during epilepsy treatment or other conditions requiring phenytoin therapy.

• Is this kit reusable, or is it meant for single-use only? How should it be stored?

  The kit is intended for single-use only, meaning each assay and calibrator set should not be reused after opening. Storage requires only standard laboratory conditions—no special refrigeration or environmental controls are specified, but it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory pathway was followed for this device, and when was it cleared?

  This device followed the FDA 510(k) clearance process, specifically a *Traditional* review route, and was determined to be substantially equivalent to a predicate device. It received clearance on November 5, 1986, under the classification of a Class II device (regulation 862.3250) for Free Radical Assays, Cocaine, and related substances in clinical toxicology.

• Can this assay be used in environments with MRI machines, or are there any restrictions?

  The device is not intended for use in MRI environments. While the kit itself does not contain metallic components that would interfere with MRI, the manufacturer explicitly excludes its use in such settings, likely due to potential contamination risks or procedural incompatibilities in clinical toxicology labs near MRI facilities.