R&D Systems Body Fluid-I Hematology Control
by R&D Systems, Inc. United States EUDAMED510(k)
510(k) K101578 Product code JPK
Overview
The R&D Systems Body Fluid-I Hematology Control is a mixture classified under hematology quality control, designed to monitor the performance of instruments measuring red and white blood cell counts in body fluids such as cerebrospinal, serous, and synovial fluids. It contains mammalian erythrocytes and leukocytes suspended in a plasma-like fluid, providing two distinct levels to assess both normal and abnormal cell count ranges.
This product is supplied as a liquid control for manual hemocytometer use, intended for in vitro diagnostic (IVD) applications. It is regulated under FDA 510(k) clearance (K101578) and the EU In Vitro Diagnostic Device Directive (IVDD), with a classification of Class II. Storage and handling conditions are not specified but must comply with standard IVD quality control protocols to ensure accuracy and reliability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK101578 | Date28 Apr 2011 | 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- Withdrawn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 types of body fluids is this hematology control designed to monitor in clinical settings?
This control is specifically formulated to simulate red and white blood cell counts in body fluids such as cerebrospinal, serous, and synovial fluids. It is not intended for whole blood or other fluid types, but rather for assessing instrument performance in non-blood body fluids where hematology measurements may be relevant.
How is the R&D Systems Body Fluid-I Hematology Control supplied, and is it intended for single-use or reuse?
The product is supplied as a liquid control, intended exclusively for manual hemocytometer use. Since it is classified as a quality control mixture for in vitro diagnostic applications, it is designed for single-use only to ensure accuracy and prevent cross-contamination between tests.
Does this control come in multiple levels, and if so, what purpose do they serve?
Yes, the control provides two distinct levels to evaluate both normal and abnormal cell count ranges. This dual-level design allows users to assess instrument performance across a broader spectrum, ensuring reliability in detecting variations in red and white blood cell counts within body fluids.
What regulatory pathways has this device undergone, and where is it authorized for use?
The device has received FDA clearance under the 510(k) pathway (K101578) and complies with the EU In Vitro Diagnostic Device Directive (IVDD). It is authorized for use in markets where these regulatory pathways apply, including the United States and the European Economic Area, though specific country requirements should be verified.
Are there specific storage instructions provided for this control, or should it follow general IVD quality control protocols?
The manufacturer does not specify unique storage conditions beyond standard IVD quality control protocols. To maintain accuracy and reliability, it should be stored according to general in vitro diagnostic control guidelines, typically at refrigerated temperatures (2–8°C) and protected from light until use.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K101578
- EUDAMED