Randox Liquid CK-MB, Randox CK-MB Calibrator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123977 FDA 510(k)
- FDA Product Code
- CGS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1215 FDA 510(k)
- Regulation Number
- 862.1215 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Randox Liquid CK-MB and Randox CK-MB Calibrator are in vitro diagnostic reagents used for the measurement of creatine kinase-MB isoenzyme (CK-MB) in serum or plasma. CK-MB is a biomarker for myocardial infarction, and these products are designed to support accurate quantification of CK-MB activity in clinical chemistry assays, aiding in the diagnosis and monitoring of cardiac events.
The Randox Liquid CK-MB is supplied as a liquid reagent for use in automated clinical chemistry analyzers, while the Randox CK-MB Calibrator provides a single-point calibration material with a human serum-based matrix. Both are intended for single-use and are not sterile or reusable. They are classified as Class II devices under FDA regulations and are authorized for use in clinical laboratories. Storage conditions and regulatory compliance are governed by the manufacturer’s specifications and FDA clearance (K123977).
Frequently asked questions
What clinical role do the Randox Liquid CK-MB and CK-MB Calibrator play in diagnosing cardiac events?
These reagents are designed to measure creatine kinase-MB isoenzyme (CK-MB) levels in serum or plasma, a key biomarker for myocardial infarction (heart attack). The Randox Liquid CK-MB provides the liquid reagent for accurate CK-MB quantification in automated clinical chemistry analyzers, while the CK-MB Calibrator ensures precise single-point calibration using a human serum-based matrix. Together, they support reliable diagnosis and monitoring of cardiac events by enabling precise CK-MB activity measurements.
Are the Randox Liquid CK-MB and CK-MB Calibrator intended for reuse or single-use, and how should they be stored?
Both the Randox Liquid CK-MB and CK-MB Calibrator are explicitly designed for single-use only and are not sterile or reusable. Storage conditions are governed by the manufacturer’s specifications, which should be consulted for exact details, but generally, in vitro diagnostic reagents like these are stored under controlled conditions (e.g., refrigerated or at room temperature) to maintain stability and accuracy until use.
What type of clinical chemistry analyzers are compatible with the Randox Liquid CK-MB reagent?
The Randox Liquid CK-MB is formulated specifically for use in automated clinical chemistry analyzers, though compatibility depends on the analyzer’s capabilities for measuring CK-MB isoenzyme activity. The manufacturer’s instructions should be reviewed to confirm compatibility with your specific analyzer model, as not all systems support liquid reagents for CK-MB quantification.
How does the Randox CK-MB Calibrator differ from the Liquid CK-MB reagent in terms of function?
The Randox Liquid CK-MB is the assay reagent used to measure CK-MB levels in patient samples, enabling accurate quantification of the biomarker in serum or plasma. In contrast, the Randox CK-MB Calibrator is a single-point calibration material with a human serum matrix, providing a standardized reference to ensure the analyzer’s measurements are precise and consistent. Together, they form a complete workflow for reliable CK-MB testing.
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: Randox | Global Healthcare, CK-MB Calibrator - Randox Online Store, CK-MB - Randox Laboratories, CK-MB Quality Control | Randox Laboratories
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123977 | Class II | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA 510(k) K123977 24 fields · synced Sep 19, 2026