Pentra 5D Hematology Quality Control Mixture
by R&D Systems, Inc. United States 510(k)
510(k) K003534 Product code JPK
Overview
The Pentra 5D is a Hematology Quality Control Mixture, classified as a mixture device under FDA product code JPK. It is designed to evaluate the accuracy and precision of hematology analyzers 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), and other derived values. This device supports both manual and automated hematology testing systems by providing standardized reference materials for calibration and quality assurance.
The Pentra 5D is supplied as a sterile, single-use mixture intended for laboratory settings. It is regulated under FDA regulation number 864.8625 and cleared through the Traditional 510(k) pathway (K003534). The device is classified as a Class II medical device and is distributed in multiple lot numbers for traceability. Storage and handling instructions are specified in the accompanying documentation, ensuring stability and reliability for hematology quality control purposes.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003534 | Date1 Dec 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Pentra 5D
- 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 Pentra 5D used for?
The Pentra 5D is a hematology quality control mixture designed to evaluate the accuracy and precision of hematology analyzers. It provides standardized reference materials for calibrating and validating measurements of key cell parameters, including white blood cell count (WBC), red blood cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), and other derived hematology values. This ensures reliable performance of both manual and automated hematology testing systems.
How is the Pentra 5D supplied and what are its key features?
The Pentra 5D is supplied as a sterile, single-use mixture, ensuring consistency and safety for laboratory use. It is intended exclusively for quality control purposes in hematology testing. Each lot is uniquely numbered for traceability, and the device is classified under FDA product code JPK as a mixture device. The accompanying documentation includes detailed storage and handling instructions to maintain stability and reliability.
Is the Pentra 5D reusable or single-use?
The Pentra 5D is explicitly designed for single-use only. This design choice ensures that each measurement is performed with a fresh, uncontaminated sample, reducing the risk of cross-contamination and maintaining the integrity of quality control results. Single-use also aligns with best practices for laboratory safety and precision.
What storage requirements does the Pentra 5D have?
The Pentra 5D must be stored according to the instructions provided in the accompanying documentation to preserve its stability and effectiveness. Proper storage conditions typically include protection from extreme temperatures, light exposure, and physical damage. Adhering to these guidelines ensures the mixture remains suitable for accurate quality control assessments in hematology testing.
What regulatory pathway was followed for the Pentra 5D?
The Pentra 5D was cleared through the Traditional 510(k) pathway by the FDA, with clearance number K003534. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for Class II medical devices. The device is also regulated under FDA regulation number 864.8625.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K003534