CBC-CAL Plus Hematology Calibrator
by R&D Systems, Inc. EUDAMED510(k)GUDID
Active
510(k) K955925Ref 0CP020TA3
Overview
The CBC-CAL Plus Hematology Calibrator is a Calibrator for Cell Indices, designed to ensure accurate performance of hematology analyzers by providing standardized reference values for red blood cell, white blood cell, and platelet parameters. It is classified as a Class II medical device under FDA regulations and serves as a quality control tool in hematology laboratories.
This device is intended for single-use calibration of automated hematology instruments, supplied sterile and packaged individually. It requires no special storage conditions and is compatible with standard laboratory environments. Authorized for use in the United States under FDA 510(k) clearance (K955925) and compliant with the EU In Vitro Diagnostic Regulation (IVDR), it is distributed under product code KRX and registration numbers listed in the OpenFDA database.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number0815762028CPC3 | Date18 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00815762023453 | Date1 Dec 2025 | StatusIn distribution |
| United States | FDA 510(k)SESE 510(k) | NumberK955925 | Date29 Feb 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Cbc-Cal Plus EUDAMEDResearch and Diagnostic Systems GUDID
- Generic Name
- Full blood count IVD, calibrator
- Device Name
- NCAL1
- Model / Reference
- 0CP020TA3
- Primary DI / UDI-DI
- 00815762023453
- 510(k) Number
- FDA Product Code
- KRX
- GMDN Term
- Full blood count IVD, calibrator
- Regulation
- 21 CFR Part 864.8150
- Market of Registration
- France
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | 510(k) | GUDID |
|---|---|---|---|
| Device Class | Class B | Class II | Class II |
Other devices from R&D Systems, Inc.
Questions
What is the CBC-CAL Plus Hematology Calibrator used for in a clinical setting?
The CBC-CAL Plus Hematology Calibrator is designed to ensure the accuracy of automated hematology analyzers by providing standardized reference values for red blood cell, white blood cell, and platelet parameters. It acts as a quality control tool to maintain precision in laboratory measurements, helping to verify that instruments are performing correctly for cell index analysis.
Is the CBC-CAL Plus Hematology Calibrator intended for single-use or repeated use?
The device is explicitly intended for single-use calibration of hematology analyzers. Each unit is sterile, packaged individually, and should not be reused after opening or use, as this could compromise accuracy and sterility.
What storage conditions are required for the CBC-CAL Plus Hematology Calibrator?
No special storage conditions are required. The device is compatible with standard laboratory environments, meaning it can be stored at typical room temperature without refrigeration or additional precautions.
How do I know if this calibrator is compatible with my hematology analyzer?
The CBC-CAL Plus is specifically designed for cell indices calibration, which includes red blood cell, white blood cell, and platelet parameters. While compatibility depends on your analyzer’s manufacturer specifications, it is widely used in hematology laboratories for quality control. Always verify with your analyzer’s documentation or manufacturer to confirm suitability.
What regulatory approvals does the CBC-CAL Plus Hematology Calibrator hold?
The device holds FDA 510(k) clearance (K955925) under the Traditional pathway, classified as a Class II medical device. It is also compliant with the EU In Vitro Diagnostic Regulation (IVDR), ensuring it meets both U.S. and European regulatory standards for hematology calibration tools.