Sysmex Automated Coagulation Analyzer Model CA-6000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K001145 ↗

FDA Product Code

GKP

Device Class

Class II

Regulation

21 CFR Part 864.5400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What types of coagulation tests does the Sysmex CA-6000 perform?

  The Sysmex CA-6000 automated coagulation analyzer conducts clotting assays, chromogenic assays, and immunoturbidimetric assays. This includes measuring D-Dimer levels, which are critical for assessing conditions like venous thromboembolism or disseminated intravascular coagulation. The analyzer uses optical detection technology to deliver precise results for key hemostasis parameters in blood samples.

• Is the Sysmex CA-6000 designed for single-use or reusable applications?

  The Sysmex CA-6000 is a reusable medical device, intended for use in clinical hematology laboratories. While it is not specified as sterile, it is engineered for reliable performance in laboratory settings where proper maintenance, calibration, and cleaning protocols are followed. Reusability extends its utility in low-volume labs or as a backup system in larger facilities.

• How does the true random access mode benefit laboratory workflows?

  The true random access mode of the Sysmex CA-6000 allows laboratories to process coagulation tests in any order, without needing to run them sequentially. This flexibility optimizes workflow efficiency, especially in settings with variable testing demands or limited staffing. It integrates seamlessly into existing laboratory systems, reducing bottlenecks and improving turnaround times for critical hemostasis assessments.

• What regulatory clearance does the Sysmex CA-6000 hold in the U.S.?

  The Sysmex CA-6000 received FDA clearance through a 510(k) submission, classified under product code GKP (General and Plastic Surgery Instruments) and categorized as a Class II device. This clearance confirms its substantial equivalence to a predicate device, ensuring it meets U.S. regulatory standards for safety and performance in coagulation testing. The device is also associated with the Hematology advisory committee.

• What storage and operational conditions are required for the Sysmex CA-6000?

  The Sysmex CA-6000 must be stored and operated according to the manufacturer’s guidelines to ensure accurate and reliable coagulation testing. Proper maintenance, including regular calibration and cleaning, is essential for optimal performance. Environmental conditions such as temperature, humidity, and electrical stability should align with the device’s specifications to prevent operational errors or compromised test results.