Creatinine for Continuous Flow Instruments

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K881400 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase (Alt)/(Gpt)

  Class I

  FDA 510(k) K870086 Active Cleared 6 Mar 1987

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  Class I

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• Uric Acid for Manual/Automated Applications

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  FDA 510(k) K895821 Active Cleared 5 Dec 1989

See all devices from Catachem, Inc. →

• What is the Catachem Creatinine Reagent for Continuous Flow used for?

  This reagent is designed for measuring creatinine levels in serum or plasma samples using automated continuous flow analyzers. It employs alkaline picrate colorimetry to produce a colorimetric change proportional to creatinine concentration, allowing for rapid and accurate quantitative analysis in clinical chemistry laboratories.

• How is the Catachem Creatinine Reagent supplied and intended for use?

  The reagent is supplied as a liquid specifically for use in continuous flow analyzers. It is intended for single-use applications in clinical chemistry laboratories, where it integrates seamlessly with automated systems to streamline creatinine testing workflows.

• Does the Catachem Creatinine Reagent require sterility or special handling?

  The device does not specify sterility requirements, meaning it is not intended for sterile procedures or applications where aseptic conditions are mandatory. However, proper storage and handling are essential to maintain its stability and ensure accurate test results.

• What regulatory pathway does this creatinine reagent follow?

  The Catachem Creatinine Reagent for Continuous Flow has undergone FDA review through a 510(k) clearance process, specifically under the Traditional clearance type. It was authorized by Catachem, Inc., and classified under the Clinical Chemistry advisory committee, adhering to regulatory standards outlined in 21 CFR 862.1225.

• Are there specific storage requirements for this reagent?

  While the exact storage conditions are not detailed in the provided data, reagents like this typically require protection from light, extreme temperatures, and contamination. Always follow the manufacturer’s instructions for optimal performance and shelf life, as improper storage could compromise accuracy or stability.