Medica EasyQC Hematocrit Control
by Bionostics, Inc. 510(k)
Active
510(k) K021924
Overview
Medica EasyQC Hematocrit Control is a two-level, non-hazardous, aqueous electrolyte solution that simulates clinically relevant hematocrit concentrations via conductivity. It is used in clinical laboratories to perform periodic quality control checks on the Medica EasyStat analyzer. The device provides a standardized reference to verify analytical performance and helps ensure accuracy of hematocrit measurements.
This control solution is supplied for use with the Medica EasyStat analyzer and is regulated as a Class II device under product code GLK. It is authorized as substantially equivalent under FDA 510(k) clearance number K021924, received on June 11, 2002, with a decision date of June 24, 2002. The device is intended for quality control purposes in hematology testing and is not for direct patient use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021924 | Date24 Jun 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GLK
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8625
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bionostics, Inc.
Questions
What is the Medica EasyQC Hematocrit Control used for?
The Medica EasyQC Hematocrit Control is a two-level, non-hazardous aqueous electrolyte solution used in clinical laboratories to perform periodic quality control checks on the Medica EasyStat analyzer. It simulates clinically relevant hematocrit concentrations via conductivity to verify analytical performance and ensure measurement accuracy.
How is the Medica EasyQC Hematocrit Control supplied?
The control solution is supplied specifically for use with the Medica EasyStat analyzer. It comes as a two-level system that provides standardized reference points for quality control purposes in hematology testing, helping laboratories maintain measurement accuracy.
Is the Medica EasyQC Hematocrit Control single-use or reusable?
The device is intended for quality control purposes in hematology testing and is not for direct patient use. It is supplied as a control solution that should be used according to the manufacturer's instructions to maintain the integrity of quality control procedures.
What regulatory approvals does the Medica EasyQC Hematocrit Control have?
The Medica EasyQC Hematocrit Control is regulated as a Class II device under product code GLK. It is authorized as substantially equivalent under FDA 510(k) clearance number K021924, received on June 11, 2002, with a decision date of June 24, 2002.