R&D 4K Retic
by R&D Systems, Inc. United States 510(k)
510(k) K010470 Product code JPK
Overview
The R&D 4K Retic is a Hematology Quality Control Mixture (product code JPK), classified as a Class II device under FDA regulation 864.8625. It is designed to verify the accuracy and precision of hematological instruments in measuring key cell parameters, including white blood cell count (WBC), red blood cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
Supplied as 4 × 3 mL vials (2 each of Level 1 and Level 2 controls), the device is intended for use in laboratory settings to monitor and maintain the performance of manual, semiautomated, and automated hematology analyzers. It is not sterile and is classified as a reusable control mixture for quality assurance purposes, with no specific MRI safety considerations noted. Authorized under FDA 510(k) clearance (K010470), it adheres to Special Controls for hematology quality control mixtures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010470 | Date11 May 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
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 hematology analyzers is the R&D 4K RETIC designed to validate, and how is it supplied for use?
The R&D 4K RETIC is specifically designed to verify the accuracy and precision of manual, semiautomated, and automated hematology analyzers by measuring key parameters like WBC, RBC, platelet count, hemoglobin, and more. It comes as four 3 mL vials—two vials each of Level 1 and Level 2 controls—to simulate different patient sample conditions for comprehensive quality assurance.
Is the R&D 4K RETIC intended for single-use or repeated use, and what does that mean for my lab’s workflow?
The R&D 4K RETIC is classified as a reusable control mixture for quality assurance, meaning it can be used repeatedly within your lab’s quality control protocols. This allows for consistent monitoring of analyzer performance over time without the need for frequent replacements, though proper storage and handling are required to maintain stability.
What storage conditions should I follow to ensure the R&D 4K RETIC remains effective for quality control testing?
While the exact storage instructions aren’t detailed in the provided data, as a non-sterile, reusable hematology control mixture, it should be stored according to standard laboratory practices for liquid controls—typically at room temperature (15–25°C) or refrigerated (2–8°C) if specified by the manufacturer. Always check the label or accompanying documentation for precise guidelines to preserve its stability and accuracy.
How does the R&D 4K RETIC differ from other hematology controls, and why might my lab choose this one?
The R&D 4K RETIC includes two distinct control levels (Level 1 and Level 2), which helps labs validate analyzer performance across a broader range of patient sample conditions. This dual-level approach ensures broader coverage of potential measurement variations, making it suitable for labs that need to confirm both normal and abnormal reference ranges. Its FDA 510(k) clearance also indicates it meets regulatory standards for hematology quality control mixtures.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K010470