Behring Coagulation System (BCS)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K000973 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Dade Behring, Inc. →

• What types of tests can the Behring Coagulation System (BCS) perform, and how does it analyze human plasma samples?

  The Behring Coagulation System (BCS) is designed to perform coagulometric, chromogenic, and immunochemical assays on human citrated plasma samples. It operates as a fully automated photometric analyzer, enabling diagnostic testing for coagulation disorders by measuring specific biochemical and hematological parameters in vitro.

• Is the Behring Coagulation System (BCS) intended for use in specific clinical settings, and if so, where?

  Yes, the BCS is specifically intended for use in clinical laboratories. It is not designed for point-of-care or bedside testing but is optimized for automated, high-volume diagnostic testing in controlled laboratory environments.

• What regulatory pathway was followed for FDA clearance of the Behring Coagulation System (BCS), and what does this mean for its use?

  The BCS received FDA 510(k) clearance under the Traditional review pathway, which means it was determined to be substantially equivalent to a legally marketed device in terms of technology and safety. This clearance allows it to be legally marketed and used in the United States for its intended purpose in clinical laboratories.

• Does the Behring Coagulation System (BCS) come with any specific storage or handling requirements?

  The provided data does not explicitly detail storage or handling requirements for the BCS itself, but as a clinical laboratory device, it is typically recommended to follow manufacturer guidelines for proper storage conditions (e.g., temperature, humidity) to ensure optimal performance and longevity. Since it is an automated analyzer, its components may require calibration and maintenance as outlined in the user manual.

• Are there multiple configurations or models of the Behring Coagulation System (BCS), and how are they differentiated?

  The BCS is associated with multiple registration numbers and product codes, indicating there may be different assay configurations or software versions available for various coagulation tests. These variations likely correspond to specific test panels or upgrades, but the core device remains a multipurpose photometric analyzer for hematology applications. For exact model differentiation, refer to the manufacturer’s documentation or contact Dade Behring, Inc.