Phenytoin Fpia Calibrators

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871423 ↗

FDA Product Code

DLJ

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Total T4 FPIA Reagent Set/Calibrator #T-1039, T-116

  Class II

  FDA 510(k) K932980 Active Cleared 18 Oct 1993

• Sigma Diagnostics Infinity Glucose Reagent, Models 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

  Class II

  FDA 510(k) K001403 Active Cleared 10 Aug 2000

• Albumin (Bcg) Reagent

  Class II

  FDA 510(k) K861467 Active Cleared 23 May 1986

• Bile Acids Calibrator

  Class II

  FDA 510(k) K872451 Active Cleared 21 Aug 1987

• Aspartate Aminotransferase Procedure No.. 58-Uv

  Class II

  FDA 510(k) K954839 Active Cleared 5 Jan 1996

• Ethanol Controls, Urine, Levels 1, II, and III

  Class I

  FDA 510(k) K932067 Active Cleared 16 Jun 1993

See all devices from Sigma Diagnostics, Inc. →

• What is the intended use of Phenytoin FPIA Calibrators?

  Phenytoin FPIA Calibrators are drug-specific calibrators used in clinical toxicology to measure phenytoin levels, enabling accurate quantification of the anticonvulsant drug in patient samples for therapeutic monitoring and toxicity assessment.

• How are Phenytoin FPIA Calibrators supplied and what is their regulatory classification?

  These calibrators are supplied as drug-specific reagents for in vitro diagnostic use, classified as Class 2 medical devices under product code DLJ, and were cleared via FDA 510(k) K871423 through the traditional pathway based on substantial equivalence to a predicate device.

• What regulatory pathway and clearance details apply to Phenytoin FPIA Calibrators?

  The device received FDA 510(k) clearance K871423 on June 11, 1987, following a 63-day review under the traditional pathway, and was determined to be substantially equivalent to a legally marketed device, with no requirement for premarket approval.