Behring Coagulation System, Model BCS
by Dade Behring, Inc. 510(k)
Active
510(k) K002080
Overview
The Behring Coagulation System, Model BCS, is a System, Multipurpose for In Vitro Coagulation Studies (product code JPA). It is designed for automated photometric analysis of coagulation parameters in clinical hematology, enabling chromogenic, coagulometric, and immunochemical assays on human citrated plasma samples. The system measures coagulation reactions and immuno complexes through photometric detection at multiple wavelengths, supporting comprehensive coagulation testing.
The Model BCS is intended for use in clinical laboratories and operates as a fully automated analyzer. Supplied as a reusable device, it requires appropriate laboratory infrastructure and maintenance. The system is classified under FDA’s Class II – Special Controls and holds an FDA 510(k) clearance (K002080). No specific MRI safety or sterility classifications are noted in the regulatory data, though standard laboratory hygiene practices apply. The device is authorized for use in the United States under regulation number 864.5425.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002080 | Date16 Nov 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5425
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the Behring Coagulation System, Model BCS used for?
The Behring Coagulation System, Model BCS, is designed for automated photometric analysis of coagulation parameters in clinical hematology. It performs chromogenic, coagulometric, and immunochemical assays on human citrated plasma samples, enabling precise measurement of coagulation reactions and immuno complexes through photometric detection at multiple wavelengths. This system is intended for comprehensive coagulation testing in clinical laboratory settings.
Is the Behring Coagulation System, Model BCS a single-use or reusable device?
The Behring Coagulation System, Model BCS is a reusable device. It requires appropriate laboratory infrastructure, maintenance, and adherence to standard laboratory hygiene practices to ensure reliable performance and safety.
What types of assays does the Behring Coagulation System, Model BCS support?
The Model BCS supports three primary types of assays: chromogenic assays (which measure coagulation factors via colorimetric reactions), coagulometric assays (which measure clotting times), and immunochemical assays (which detect immune complexes or specific proteins). These capabilities allow for a broad range of coagulation testing, including the evaluation of bleeding and clotting disorders.
Does the Behring Coagulation System, Model BCS require any special storage conditions?
While the device itself is reusable and not explicitly classified for sterility, it must be stored in a clean, controlled laboratory environment to prevent contamination and ensure proper functionality. Standard laboratory hygiene practices, including regular cleaning and maintenance, are essential to maintain performance and reliability.
What regulatory approvals does the Behring Coagulation System, Model BCS hold?
The Behring Coagulation System, Model BCS holds an FDA 510(k) clearance (K002080) under the product code JPA, classified as a Class II device under Special Controls for in vitro coagulation studies. It is authorized for use in the United States under regulation number 864.5425 and is intended for clinical laboratory use.