Cell-Dyn 3200 System with Absolute and Percent Reticulocyte
by Abbott Laboratories 510(k)
Active
510(k) K012934
Overview
The Cell-Dyn 3200 System with Absolute and Percent Reticulocyte is a multiparameter automated hematology analyzer. It performs in vitro diagnostic testing to measure and differentiate blood cell parameters, including absolute and percent reticulocyte counts, for clinical laboratory and physician office use.
This device is intended for use in clinical settings and is supplied as a reusable instrument. It operates under regulatory authorization through an FDA 510(k) clearance (K012934) as a Class II medical device. The system requires proper calibration, maintenance, and adherence to manufacturer guidelines for accurate hematological analysis.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012934 | Date28 Sep 2001 | 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- Withdrawn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 types of blood cell parameters can the Cell-Dyn 3200 System measure, and how does it differentiate between them?
The Cell-Dyn 3200 System is designed to measure and differentiate multiple blood cell parameters, including absolute and percent reticulocyte counts. It performs in vitro diagnostic testing to analyze hematological values, such as red blood cell, white blood cell, and platelet parameters, providing detailed differentiation for clinical assessment. This multiparameter capability helps laboratories and physicians evaluate blood health comprehensively.
Is the Cell-Dyn 3200 System intended for use in physician offices or only clinical laboratories?
The Cell-Dyn 3200 System is intended for use in both clinical laboratories and physician offices, as explicitly stated in its description. This flexibility allows smaller or outpatient settings to perform automated hematology analysis without needing a full lab infrastructure.
How is the Cell-Dyn 3200 System supplied, and is it single-use or reusable?
The Cell-Dyn 3200 System is supplied as a reusable instrument, meaning it is designed for repeated use in clinical settings. Proper calibration, maintenance, and adherence to manufacturer guidelines are required to ensure accurate and reliable hematological analysis over time.
What regulatory pathway does the Cell-Dyn 3200 System follow, and what does this mean for its use?
The Cell-Dyn 3200 System follows the FDA 510(k) clearance pathway, specifically classified as a Class II medical device with a clearance number K012934. This designation indicates it has been deemed substantially equivalent to a legally marketed predicate device and meets regulatory standards for safety and effectiveness in hematology testing. The system operates under this authorization for clinical laboratory and physician office use.
Does the Cell-Dyn 3200 System require any special maintenance or calibration procedures?
Yes, the Cell-Dyn 3200 System requires proper calibration and maintenance to ensure accurate and reliable performance. The manufacturer provides guidelines for these procedures, which must be followed to maintain the system’s precision in measuring blood cell parameters, including reticulocyte counts. Neglecting these steps could compromise diagnostic results.