AST Optimized Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854503 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

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

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  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 AST Optimized Reagent used for in clinical settings?

  The AST Optimized Reagent is designed for the quantitative measurement of aspartate aminotransferase (AST/SGOT) activity in patient samples. AST levels are critical for assessing liver function and detecting tissue damage, making this reagent essential for clinical chemistry analysis in laboratory settings.

• How is the AST Optimized Reagent supplied and prepared for use?

  The AST Optimized Reagent is supplied as a ready-to-use liquid reagent. No additional preparation is required before use in clinical chemistry analyzers, simplifying workflow and ensuring consistency in test results.

• Is the AST Optimized Reagent intended for single-use or reusable applications?

  This reagent is explicitly intended for single-use applications in laboratory settings. Single-use design minimizes contamination risks and ensures accurate, reproducible results for each patient sample.

• What regulatory approval does the AST Optimized Reagent hold?

  The AST Optimized Reagent has received FDA 510(k) clearance under product code CIT, confirming its compliance with U.S. medical device regulations. It is classified as a Class II device under FDA’s regulatory framework.

• How should the AST Optimized Reagent be stored?

  While the specific storage instructions are not detailed in the provided data, typical liquid reagents like this are generally stored at refrigerated temperatures (2–8°C) to maintain stability and integrity. Always refer to the manufacturer’s instructions for precise storage guidelines.