Cell-Dyn 4000 Immature Reticulocyte Fraction (IRF)
510(k) K971152
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971152 | Date12 Aug 1997 | StatusActive |
Recalls
-
- Terminated Z-0648-03
Product elicits fluorescent signal interference due to contamination.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf)
- 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
Overview
AI-generated summary, 1 Oct 2026
The Cell-Dyn 4000 Immature Reticulocyte Fraction (IRF) is an automated hematology analyzer designed to measure and report the immature reticulocyte fraction in blood samples. It functions as a differential cell counter, providing quantitative analysis of reticulocytes at various stages of maturation, which aids in assessing erythropoietic activity and diagnosing conditions affecting red blood cell production.
This device is intended for use in clinical hematology laboratories within hospitals, medical clinics, or reference laboratories. It operates as a reusable, non-sterile instrument, classified under FDA product code GKZ as a Class II device with special controls. The system requires calibration and maintenance in accordance with manufacturer guidelines, and its performance is regulated under FDA 510(k) clearance (K971152) for in vitro diagnostic use.
Other devices from Abbott Laboratories
Questions
AI-generated answers, 1 Oct 2026
What is the Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (IRF) used for?
The Cell-Dyn 4000 IRF is an automated hematology analyzer designed to measure and quantify immature reticulocytes in blood samples. These reticulocytes are young red blood cells still developing in the bone marrow, and their levels help clinicians assess erythropoietic activity—meaning how actively the body is producing new red blood cells. This information is critical for diagnosing and monitoring conditions affecting red blood cell production, such as anemia, bone marrow disorders, or responses to treatments like erythropoietin therapy.
Is the Cell-Dyn 4000 IRF a reusable or single-use device?
The Cell-Dyn 4000 IRF is a reusable instrument. It is not intended for single-use and requires calibration and maintenance as specified by the manufacturer to ensure accurate and reliable performance. Regular upkeep is essential to maintain its functionality for measuring immature reticulocyte fractions in clinical settings.
Where can the Cell-Dyn 4000 IRF be used?
This device is intended for use in clinical hematology laboratories, including hospitals, medical clinics, and reference laboratories. Its automated design and quantitative analysis capabilities make it suitable for environments where precise monitoring of erythropoietic activity is required, such as in the evaluation of patients with anemia or other blood disorders.
How is the Cell-Dyn 4000 IRF supplied, and is it sterile?
The Cell-Dyn 4000 IRF is supplied as a reusable, non-sterile instrument. Sterility is not a requirement for this device, as it is designed for use in controlled laboratory environments where proper cleaning, calibration, and maintenance protocols are followed. The manufacturer provides guidelines to ensure the device remains functional and reliable for clinical use.
What regulatory pathway does the Cell-Dyn 4000 IRF follow?
The Cell-Dyn 4000 IRF is classified under FDA product code GKZ as a Class II device with special controls. It received FDA 510(k) clearance (K971152) under the Traditional 510(k) review pathway, demonstrating substantial equivalence to a predicate device. This regulatory pathway ensures the device meets performance and safety standards for in vitro diagnostic use in clinical hematology.