Bile Acids Calibrator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K872451 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K932980 Active Cleared 18 Oct 1993

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  FDA 510(k) K861467 Active Cleared 23 May 1986

• 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

• Alp (Opt) Reagent

  Class II

  FDA 510(k) K862905 Active Cleared 29 Aug 1986

See all devices from Sigma Diagnostics, Inc. →

• What is the Bile Acids Calibrator used for?

  The Bile Acids Calibrator is designed as a secondary calibrator for clinical chemistry applications. It provides standardized reference values to validate and calibrate analytical instruments measuring bile acid concentrations in biological samples. This ensures the accuracy of diagnostic and research results by maintaining consistency in assay performance.

• How is the Bile Acids Calibrator supplied and intended for use?

  The Bile Acids Calibrator is supplied as a single-use device, meaning each unit is intended for one-time use in laboratory settings. This design minimizes contamination risks and ensures reliable calibration for each assay run.

• Is the Bile Acids Calibrator sterile?

  No, the Bile Acids Calibrator is not sterile. It is intended for use in laboratory environments where appropriate aseptic techniques can be applied. Sterility is not required for this type of calibrator, as it is not implanted or used in sterile procedures.

• What storage conditions are required for the Bile Acids Calibrator?

  The Bile Acids Calibrator must be stored under conditions specified by the manufacturer to maintain its stability and accuracy. While the exact storage instructions are not detailed here, typical recommendations for secondary calibrators include protection from extreme temperatures, light, and moisture. Always refer to the manufacturer’s guidelines for precise storage protocols.

• What regulatory status does the Bile Acids Calibrator hold?

  The Bile Acids Calibrator holds FDA 510(k) clearance under the product code JIT, classified as a Class II device under special controls. It is regulated under 21 CFR 862.1150 and is considered substantially equivalent to predicate devices in clinical chemistry. This clearance indicates it meets the regulatory requirements for safety and effectiveness as determined by the FDA.