Modification To Standard Human Plasma
by Dade Behring, Inc. 510(k)
Active
510(k) K023141
Overview
Modification to Standard Human Plasma is a lyophilized calibrator derived from pooled citrated human plasma and stabilized with a buffer solution. It is used in clinical laboratories to calibrate mechanical and photo-optical coagulation systems for various coagulation and fibrinolysis assays.
The device is reconstituted by a laboratory technician prior to use. This product is subject to FDA 510(k) clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023141 | Date16 Jan 2003 | 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- Withdrawn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 primary use of Modification to Standard Human Plasma?
This product is designed for use in clinical laboratories to calibrate mechanical and photo-optical coagulation systems. It supports the accurate performance of various coagulation and fibrinolysis assays.
How is this calibrator supplied and prepared for use?
The device is supplied as a lyophilized product derived from pooled citrated human plasma and stabilized with a buffer solution. It must be reconstituted by a laboratory technician according to standard protocols before it can be used in coagulation testing.
What is the regulatory status of this device?
Modification to Standard Human Plasma is subject to FDA 510(k) clearance. It has been determined to be substantially equivalent for its intended use in clinical coagulation studies.