Cell-Dyn Emerald 22 System
by Abbott Laboratories 510(k)
Active
510(k) K110381
Overview
The Cell-Dyn Emerald 22 System is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use. It performs differential cell counts and complete blood counts (CBCs), providing automated analysis of red blood cells, white blood cells, and platelets. The device is classified as a counter for differential cell analysis and is intended for clinical laboratory settings.
This system is supplied as a reusable, non-sterile medical device and is intended for use in clinical laboratories of varying testing volumes, including small- to mid-sized facilities. It operates under FDA 510(k) clearance (K110381) and adheres to regulatory standards outlined in 21 CFR 864.5220. The device requires proper calibration, maintenance, and storage as specified by the manufacturer to ensure accurate and reliable performance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110381 | Date22 Dec 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Cell-Dyn Emerald 22 System used for?
The Cell-Dyn Emerald 22 System is an automated hematology analyzer designed for in vitro diagnostic use. It performs complete blood counts (CBCs) and differential cell counts, analyzing red blood cells, white blood cells, and platelets. This makes it ideal for clinical laboratories to streamline hematological testing and improve diagnostic accuracy.
Is the Cell-Dyn Emerald 22 System reusable or single-use?
The Cell-Dyn Emerald 22 System is a reusable medical device. It is not intended for single-use and requires proper calibration, maintenance, and cleaning as specified by the manufacturer to ensure reliable performance and longevity.
What type of sterility does the Cell-Dyn Emerald 22 System have?
The Cell-Dyn Emerald 22 System is supplied as a non-sterile device. Sterility is not a requirement for this analyzer, as it is designed for use in controlled laboratory environments where contamination risks are managed through proper handling and maintenance procedures.
How is the Cell-Dyn Emerald 22 System supplied and where is it intended for use?
The Cell-Dyn Emerald 22 System is supplied as a reusable device and is intended exclusively for use in clinical laboratory settings. It is suitable for laboratories of varying testing volumes, including small- to mid-sized facilities, where automated hematology analysis is required.
What regulatory clearance does the Cell-Dyn Emerald 22 System hold?
The Cell-Dyn Emerald 22 System holds FDA 510(k) clearance under the reference number K110381. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and adheres to regulatory standards outlined in 21 CFR 864.5220.