Innofluor Phenytoin

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

510(k) Number

K841706 ↗

FDA Product Code

LGR

Device Class

Class II

Regulation

21 CFR Part 862.3350

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Innofluor Primidone

  Class I

  FDA 510(k) K844721 Active Cleared 8 Jan 1985

• Innoflour Tobramycin

  Class II

  FDA 510(k) K841866 Active Cleared 31 May 1984

• Innofluor Phenobarbital

  Class II

  FDA 510(k) K841707 Active Cleared 23 May 1984

• Innoflour Gentamicin

  Class II

  FDA 510(k) K841865 Active Cleared 31 May 1984

• Innofluor Theophylline

  Class II

  FDA 510(k) K850629 Active Cleared 12 Mar 1985

• What clinical setting is the Innofluor Phenytoin designed for, and how does it help in patient care?

  The Innofluor Phenytoin is specifically designed for clinical toxicology settings, where precise measurement of total diphenylhydantoin (phenytoin) levels in biological samples is critical. It uses fluorescence polarization immunoassay technology to quantify phenytoin concentrations, enabling clinicians to monitor drug levels in patients undergoing phenytoin therapy. This helps ensure therapeutic efficacy, detect toxicity, and guide dosing adjustments for safer treatment.

• Is the Innofluor Phenytoin kit reusable, or is it meant for single-use only?

  The Innofluor Phenytoin is supplied as a single-use reagent kit, meaning each kit is intended for one testing session only. This design ensures accuracy and sterility, as reuse could introduce contamination or variability in results, which is critical for reliable clinical toxicology assessments.

• What types of biological samples can the Innofluor Phenytoin measure, and how does the fluorescence polarization method work?

  The Innofluor Phenytoin is designed to measure total phenytoin levels in biological samples, though the exact sample types (e.g., serum, plasma, whole blood) are not specified in the data. The fluorescence polarization immunoassay works by binding phenytoin in the sample to a fluorescently labeled antibody. When phenytoin is present, it alters the rotation of the labeled antibody, changing the polarization of emitted fluorescence. This change is proportional to the phenytoin concentration, allowing precise quantification.

• How is the regulatory status of the Innofluor Phenytoin determined, and what does the 'LGR' product code indicate?

  The Innofluor Phenytoin received FDA 510(k) clearance under the LGR (Low-Grade Risk) product code, classifying it as a Class II device in the Clinical Toxicology category. The 'LGR' designation indicates it is regulated under FDA regulation number 862.3350, meaning it undergoes premarket review to ensure safety and effectiveness while posing minimal risk compared to higher-grade devices. This clearance was granted in 1984 after being deemed substantially equivalent to a predicate device.