R&D Body Fluid Control
by R&D Systems, Inc. United States EUDAMED510(k)
510(k) K020229 Product code JPK
Overview
The R&D Body Fluid Control is a mixture classified under hematology quality control, designed as a bi-level control for monitoring total cell counts. It contains mammalian erythrocytes and leukocytes suspended in a plasma-like fluid to simulate normal and abnormal hematological ranges, supporting manual hemocytometer analysis.
Supplied as single-use vials, this control is intended for research use only and is not approved for diagnostic procedures. It is manufactured by R&D Systems, Inc., with FDA 510(k) clearance (K020229) and IVDD compliance, adhering to regulatory standards for hematology quality control mixtures. Storage and handling follow standard laboratory protocols for biological controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK020229 | Date6 Feb 2002 | StatusActive |
| European Union | CE/IVDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- JPK
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8625
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from R&D Systems, Inc.
Questions
What is the primary purpose of the R&D Body Fluid Control, and how does it support laboratory workflows?
The R&D Body Fluid Control is designed as a bi-level hematology quality control mixture to monitor total cell counts, simulating both normal and abnormal hematological ranges. It contains mammalian erythrocytes and leukocytes suspended in a plasma-like fluid, making it ideal for validating and verifying manual hemocytometer analysis in research settings. This ensures consistent, reliable results when calibrating or troubleshooting cell counting procedures.
Is this product intended for clinical diagnostic use, or is it strictly for research purposes?
This product is explicitly labeled for research use only and is not approved for clinical diagnostic procedures. It is manufactured under FDA 510(k) clearance (K020229) and IVDD compliance, but its intended use is limited to laboratory quality control and validation in research environments, not patient care.
How is the R&D Body Fluid Control supplied, and what should I consider for storage and handling?
The product is supplied as single-use vials, ensuring sterility and consistency for each use. Storage and handling follow standard laboratory protocols for biological controls, though specific conditions (e.g., temperature, expiration) are not detailed in the data. Always refer to the manufacturer’s instructions for optimal preservation and usage.
What regulatory pathways does this device follow, and how does that affect its use?
The R&D Body Fluid Control is cleared via the FDA’s 510(k) pathway (K020229) under the Hematology advisory committee (HE) and classified as a Class II device (device class 2). It also complies with the In Vitro Diagnostic Device Directive (IVDD). These pathways ensure it meets regulatory standards for hematology quality control mixtures, but its use remains restricted to research applications as outlined in the labeling.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K020229
- EUDAMED