Sysmex Automated Coagulation Analyzer CA-500
by Dade Behring, Inc. 510(k)
Active
510(k) K981711
Overview
The Sysmex Automated Coagulation Analyzer CA-500 is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. It is a compact instrument capable of 5-parameter random analysis for in vitro coagulation studies.
The device is supplied for use in clinical laboratory settings and is authorized under FDA 510(k) clearance (K981711). It is classified as a Class II device under regulation number 864.5425 with product code JPA.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981711 | Date30 Sep 1998 | 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- Withdrawn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 Sysmex CA-500 used for?
The Sysmex CA-500 is used for in vitro diagnostic coagulation studies in clinical laboratories, performing automated analysis of blood plasma to assess coagulation parameters as a fully automated, computerized system.
How is the Sysmex CA-500 supplied and what type of analysis does it perform?
The device is supplied as a compact, fully automated instrument for clinical laboratory use and performs 5-parameter random analysis for in vitro coagulation studies, enabling random access testing of multiple coagulation parameters.
Is the Sysmex CA-500 a single-use or reusable device?
The Sysmex CA-500 is a reusable, benchtop laboratory analyzer designed for repeated use in clinical settings; it is not a single-use device but requires regular maintenance and calibration for accurate performance.