Direct LDL/HDL Cholesterol Calibrator
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Identity
- Trade Name
- DIRECT LDL/HDL CHOLESTEROL CALIBRATOR EUDAMEDD LDL/HDL CAL FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
- Device Name
- DIRECT LDL/HDL CHOLESTEROL CALIBRATOR EUDAMEDThe device is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL cholesterol clearance methods FDA UDI
- Model / Reference
- CH2673 EUDAMEDFDA UDI
- Description
- The device is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL cholesterol clearance methods FDA UDI
Identifiers
- Catalog Number
- CH2673 FDA UDI
- Primary DI / UDI-DI
- 05055273201239 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BDIHDCA02628 EUDAMED
- 510(k) Number
- K122126 FDA UDI
- FDA Product Code
- JIS FDA UDI
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Direct LDL/HDL Cholesterol Calibrator is a human serum-based calibration material designed for use in clinical chemistry analysers. It provides a dedicated solution for calibrating direct HDL (High-Density Lipoprotein) and LDL (Low-Density Lipoprotein) cholesterol assays, ensuring accurate measurement of these key lipid parameters in routine lipid profiles.
Supplied as a kit, this non-sterile device is intended for professional laboratory use and is not intended for self-testing or near-patient testing. It is packaged in sizes of 3 × 1 mL and is regulated under the FDA 510(k) pathway and the In Vitro Diagnostic Regulation (IVDR). The calibrator is classified as a Class B device and is manufactured by Randox Laboratories Limited, Crumlin, UK.
Frequently asked questions
What is the Direct LDL/HDL Cholesterol Calibrator used for in a clinical setting?
The Direct LDL/HDL Cholesterol Calibrator is designed specifically for calibrating direct HDL (High-Density Lipoprotein) and LDL (Low-Density Lipoprotein) cholesterol assays on clinical chemistry analysers. It ensures accurate measurement of these lipid parameters in routine lipid profiles, which is critical for assessing cardiovascular risk and diagnosing lipid-related conditions.
Is this calibrator suitable for self-testing or near-patient testing?
No, the Direct LDL/HDL Cholesterol Calibrator is explicitly intended for professional laboratory use only and is not approved for self-testing or near-patient testing. It is supplied as a kit for use in controlled clinical chemistry environments.
How is the Direct LDL/HDL Cholesterol Calibrator packaged and what sizes are available?
The calibrator is supplied as a kit containing 3 × 1 mL vials of human serum-based calibration material. Each vial provides a dedicated solution for direct LDL/HDL cholesterol assays, ensuring consistency across measurements in laboratory settings.
Is the Direct LDL/HDL Cholesterol Calibrator sterile, and if not, what are the implications for handling?
The calibrator is non-sterile, as indicated by the sterility field marked as `0`. Since it is intended for professional laboratory use, standard aseptic techniques should be followed during handling to prevent contamination, though it is not required to be used in a sterile environment like surgical or invasive procedures.
What regulatory pathways does this device follow, and how does that affect its use?
The Direct LDL/HDL Cholesterol Calibrator is regulated under the FDA 510(k) pathway and the In Vitro Diagnostic Regulation (IVDR) in the EU. It is classified as a Class B device, meaning it has a moderate risk level and must meet specific performance and safety standards. These regulatory routes ensure its suitability for accurate lipid measurement in clinical chemistry analysers, but they do not imply any clinical indication—only that it complies with regulatory requirements for calibration materials.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Acusera Direct LDL/HDL Cholesterol Calibrator | Randox, Direct LDL/HDL Cholesterol Calibrator - Randox Online Store, Direct LDL/HDL Cholesterol Calibrator - Randox Online Store, Lipid Control Calibrators - Randox Laboratories
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153435 | Class B | Active |
| FDA 510(k) | United States | FDA_510K | K982529 | Class B | Active |
| FDA 510(k) | United States | FDA_510K | K161691 | Class B | Active |
| FDA 510(k) | United States | FDA_510K | K122126 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 50552732BDIHDCA02628 | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (3)
- EUDAMED 59f31873-5ed7-4989-818b-8336742524ef 85 fields · synced Sep 18, 2026
- FDA UDI d1ba9567-6039-4b2a-aa7c-d801f46e4761 37 fields · synced May 30, 2026
- FDA 510(k) K153435 1 fields · synced May 18, 2026