Coagulation Control, Level II

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

510(k) Number

K902362 ↗

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 Sigma Coagulation Control Level II used for?

  This device is a Plasma, Coagulation Control (Level II) designed for in vitro diagnostic use in hematology laboratories. It serves as a quality control material to monitor and verify the accuracy of coagulation assays, ensuring reliable test results. Level II controls are specifically used for intermediate-level verification of coagulation systems, helping laboratories maintain precision in patient testing.

• How is the Sigma Coagulation Control Level II supplied and stored?

  The product is supplied as a sterile, single-use reagent, meaning each unit is intended for one-time use only to prevent contamination. It must be stored refrigerated at 2–8°C to preserve its stability and efficacy. Proper refrigeration is critical to maintaining the integrity of the plasma-based control material.

• Is this device reusable or intended for single-use?

  This device is strictly single-use only. As a sterile reagent, it is designed for one-time use in coagulation testing to ensure accuracy and prevent cross-contamination between samples. Reuse is not recommended and could compromise test reliability.

• What regulatory approval does the Sigma Coagulation Control Level II hold?

  The device holds FDA 510(k) clearance (K902362) and is classified as a Class II medical device under the FDA’s regulatory framework. It adheres to FDA regulation 864.5425 for plasma-based controls and was reviewed by the Hematology (HE) Advisory Committee as part of its clearance process. No third-party review was involved in this submission.

• What storage conditions are required for this product?

  The Sigma Coagulation Control Level II must be stored refrigerated between 2–8°C to maintain its stability and performance. Deviations from this temperature range could alter the product’s properties, potentially affecting the accuracy of coagulation assays. Always check the label for expiration dates and storage instructions before use.