Coagulation Control, Level I

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K902361 ↗

FDA Product Code

GGN

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Coagulation Control, Level I used for in a laboratory setting?

  The Coagulation Control, Level I is a plasma-based calibration standard designed to ensure the accuracy and precision of coagulation testing instruments. It serves as a reference material for monitoring and maintaining the performance of assays that measure critical clotting factors, fibrinogen, and other coagulation parameters in blood samples. By using this control, laboratories can validate their equipment and processes, reducing the risk of inaccurate test results.

• How is the Coagulation Control, Level I supplied and intended for use?

  This device is supplied as a liquid reagent and is intended for single-use in clinical laboratory settings. It is not meant for reuse or repeated applications, as its stability and accuracy are preserved only for one use per vial. Laboratories should follow manufacturer guidelines to ensure proper handling and usage to maintain the integrity of coagulation testing.

• What storage conditions are required to maintain the stability of the Coagulation Control, Level I?

  The Coagulation Control, Level I must be stored under controlled temperatures to preserve its stability and performance. While the exact temperature range is not specified in the provided data, most plasma-based calibration standards require refrigeration (typically between 2°C and 8°C) to prevent degradation. Always refer to the manufacturer’s instructions for precise storage guidelines to avoid compromising the reagent’s accuracy.

• Is the Coagulation Control, Level I sterile, and if so, how is sterility maintained?

  The provided data does not explicitly state whether the Coagulation Control, Level I is sterile, but as a plasma-based liquid reagent intended for clinical use, it is reasonable to assume it undergoes standard sterilization processes (such as filtration or heat treatment) during manufacturing. Sterility is critical for laboratory reagents to prevent contamination of blood samples. If sterility is a concern, laboratories should confirm this with Sigma Chemical Co. or consult the product documentation.

• What regulatory pathway does the Coagulation Control, Level I follow, and what does this mean for users?

  The Coagulation Control, Level I is classified under FDA product code GGN as a Class II medical device with special controls, regulated under 21 CFR 864.5425. It was granted FDA 510(k) clearance (K902361) in 1990, meaning it was determined to be substantially equivalent to a legally marketed device at the time. This classification ensures it meets established safety and performance standards for use in clinical hematology laboratories, though users should always verify compliance with current regulatory requirements and manufacturer instructions.