R&D Retic-PG Hematology Control
by R&D Systems, Inc. United States EUDAMED510(k)
510(k) K961673 Product code JPK
Overview
The R&D Retic-PG Hematology Control is a tri-level, assayed hematology quality control mixture designed for monitoring reticulocyte values. Classified as a Hematology Quality Control under FDA regulation 864.8625, it serves as a reference standard to validate and ensure accuracy in hematology testing systems, particularly those measuring reticulocyte counts.
Supplied as a sterile, single-use liquid control, this device is intended for use in clinical laboratories with hematology analyzers. It is regulated under both FDA 510(k) clearance (K961673) and the EU’s In Vitro Diagnostic Regulation (IVDR). Storage conditions and specific lot identification are detailed on the packaging, with multiple FEI numbers (e.g., 1950302, 3010939897) listed for traceability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK961673 | Date15 Jul 1996 | StatusActive |
| European Union | CE/IVDR 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- Withdrawn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 R&D Retic-PG Hematology Control specifically designed to monitor in hematology testing systems?
The R&D Retic-PG Hematology Control is a tri-level liquid control mixture specifically designed to monitor and validate reticulocyte values in hematology testing systems. It serves as a reference standard to help ensure the accuracy and reliability of reticulocyte count measurements, which are critical for assessing red blood cell production and diagnosing conditions like anemia or bone marrow disorders.
Is the R&D Retic-PG Hematology Control intended for single-use or repeated use in a clinical setting?
The R&D Retic-PG Hematology Control is supplied as a sterile, single-use liquid control. This design ensures consistency and reliability for each test run, reducing the risk of contamination or degradation from repeated use, which is particularly important for maintaining accurate hematology measurements.
How should the R&D Retic-PG Hematology Control be stored, and what information is provided for traceability?
Storage conditions for the R&D Retic-PG Hematology Control are detailed on the packaging, though specific instructions are not provided in the data. For traceability, the device includes multiple FEI numbers (e.g., 1950302, 3010939897) listed on the packaging, allowing laboratories to track individual lots and ensure compliance with regulatory requirements.
What regulatory pathways has the R&D Retic-PG Hematology Control undergone, and which agencies have cleared or authorized it?
The R&D Retic-PG Hematology Control has undergone FDA 510(k) clearance with the reference number K961673, classified as substantially equivalent under FDA regulation 864.8625 for Hematology Quality Control. It is also authorized under the EU’s In Vitro Diagnostic Regulation (IVDR), ensuring compliance with both U.S. and European regulatory standards for hematology controls.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K961673
- EUDAMED