AMAX CS-190 Coagulation Analyzer System
by Sigma Diagnostics, Inc. 510(k)
Active
510(k) K955720
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955720 | Date13 Mar 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 25 Sep 2026
The AMAX CS-190 Coagulation Analyzer System is a multipurpose system for in vitro coagulation studies. It is designed for the detection of fibrin formation using either mechanical (ball method) or photo-optical principles to perform clot-based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.
The device is supplied as a laboratory instrument for use in clinical laboratory settings. It is a reusable system requiring appropriate maintenance and calibration. The device has received FDA 510(k) clearance under K955720 and is classified as a Class II medical device under regulation number 864.5425, with product code JPA.
Other devices from Sigma Diagnostics, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the AMAX CS-190 Coagulation Analyzer System used for?
The AMAX CS-190 is designed for in vitro coagulation studies, detecting fibrin formation via mechanical (ball method) or photo-optical principles to perform clot-based tests including prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests in clinical laboratory settings.
Is the AMAX CS-190 Coagulation Analyzer System reusable or single-use?
The AMAX CS-190 is a reusable system intended for repeated use in clinical laboratories, requiring appropriate maintenance and calibration to ensure consistent performance and accuracy over time.
What type of authorization does the AMAX CS-190 Coagulation Analyzer System have?
The device has received FDA 510(k) clearance under submission number K955720, indicating it was found substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device under regulation 864.5425 with product code JPA.