Innofluor Valproic Acid Calibrator Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K911466 ↗

FDA Product Code

DLJ

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Innofluor(Tm) Digitoxin Reagent Set

  Class II

  FDA 510(k) K913187 Active Cleared 23 Sep 1991

• Abc Fp Analyzer

  Class I

  FDA 510(k) K883533 Active Cleared 15 Dec 1988

• Progesterone System by Eia

  Class I

  FDA 510(k) K864156 Active Cleared 24 Nov 1986

• Innofluor(Tm) Valproic Acid Reagent Set

  Class II

  FDA 510(k) K911688 Active Cleared 5 Jul 1991

• Innofluor(Tm) Digitoxin Calibrator Set

  Class II

  FDA 510(k) K913186 Active Cleared 30 Aug 1991

• What is the Innofluor Valproic Acid Calibrator Set used for in clinical settings?

  The Innofluor Valproic Acid Calibrator Set is designed specifically for use in enzyme immunoassays to measure and quantify valproic acid levels in biological samples. It ensures accurate and reliable calibration of assays, which is critical for diagnostic and monitoring purposes in clinical toxicology, particularly when assessing valproic acid concentrations in patients.

• Is the Innofluor Valproic Acid Calibrator Set intended for single-use or repeated use?

  The Innofluor Valproic Acid Calibrator Set is explicitly labeled as a single-use product. This design ensures consistency and reliability in assay results, as reuse could compromise the integrity of the calibrator solutions.

• How should the Innofluor Valproic Acid Calibrator Set be stored, and does it require refrigeration?

  The set is packaged for storage at room temperature, meaning it does not require refrigeration. This makes it convenient for laboratories to maintain without specialized storage conditions, though proper handling should still follow standard laboratory practices.

• What regulatory pathway was followed for FDA clearance of this calibrator set?

  The Innofluor Valproic Acid Calibrator Set received FDA 510(k) clearance under the traditional review pathway, with a clearance number of K911466. It was determined to be substantially equivalent to a predicate device and falls under the classification of Class II (21 CFR 862.3200), which is typical for drug-specific calibrators used in clinical toxicology.

• Can this calibrator set be used with any immunoassay procedure, or is it validated for specific methods?

  The set is intended for use in *validated* immunoassay procedures, ensuring compatibility with assays designed to measure valproic acid. While it is not restricted to a single method, its performance is optimized for assays that require precise calibration to maintain accuracy and reliability in clinical toxicology testing.