Phenytoin (FPIA) Calibrator Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K861770 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• (Fpia) Assay Buffer

  Class I

  FDA 510(k) K871486 Active Cleared 8 May 1987

• Phenobarbital-Fpia Fluores. Polar. Immunoassay Kit

  Class II

  FDA 510(k) K863625 Active Cleared 10 Nov 1986

• Tobramycin Kit(Fpia)Fluorescence Polarization Immu

  Class II

  FDA 510(k) K854392 Active Cleared 5 Dec 1985

• Amikacin Kit (Fpia)

  Class II

  FDA 510(k) K862248 Active Cleared 4 Aug 1986

• Gentamicin (Fpia) Calibrator Kit

  Class II

  FDA 510(k) K861769 Active Cleared 25 Jun 1986

• Gentamicin Kit(Fpia)

  Class II

  FDA 510(k) K852013 Active Cleared 10 Jun 1985

See all devices from Windsor Laboratories, Inc. →

• What is the PHENYTOIN (FPIA) CALIBRATOR KIT used for?

  This device is a calibrator kit for phenytoin measurement using fluorescence polarization immunoassay (FPIA) methodology. It is intended for use in clinical chemistry laboratories to calibrate assays that determine phenytoin levels in patient specimens, ensuring accurate quantification of the anticonvulsant drug in serum or plasma samples.

• How is the PHENYTOIN (FPIA) CALIBRATOR KIT supplied and what is its regulatory status?

  The kit is supplied as an in vitro diagnostic reagent for calibration purposes. It received FDA 510(k) clearance (K861770) on June 25, 1986, and is classified as a Class II device under regulation number 862.1150 with product code JIS. It is manufactured by Windsor Laboratories, Inc. and is for prescription use only, meaning it must be ordered and used under the direction of a licensed healthcare professional.

• Is the PHENYTOIN (FPIA) CALIBRATOR KIT intended for single-use or reuse?

  The device is supplied as an in vitro diagnostic reagent for calibration purposes, which typically implies single-use per calibration run to prevent cross-contamination and ensure assay accuracy. While the data does not explicitly state single-use or reuse, calibrator kits in clinical chemistry are generally designed for one-time use per calibration procedure, as reconstitution or multiple uses could compromise stability and traceability to the assigned values.