Easy Lyte Calcium Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K943091 FDA 510(k)
- FDA Product Code
- JFP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1145 FDA 510(k)
- Regulation Number
- 862.1145 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyLyte Calcium Analyzer is an Electrode, Ion Specific, Calcium, designed for precise measurement of calcium ions in biological samples. Utilizing Ion Selective Electrode (ISE) technology, it automates electrolyte analysis for clinical chemistry applications, providing accurate results for whole blood, serum, plasma, or urine.
This device operates in clinical chemistry settings and is intended for single-use or reusable configurations, depending on the electrode modules. It is not MRI-safe and requires adherence to manufacturer guidelines for storage and maintenance. The analyzer is authorized under FDA_510K with a clearance type of Traditional, classified under Device Class 2 (regulation number 862.1145).
Frequently asked questions
What types of biological samples can the EasyLyte Calcium Analyzer measure, and how does it achieve this?
The EasyLyte Calcium Analyzer is designed to measure calcium ions in whole blood, serum, plasma, or urine samples. It uses Ion Selective Electrode (ISE) technology to automate and provide precise electrolyte analysis for clinical chemistry applications, ensuring accurate results across these sample types.
Is the EasyLyte Calcium Analyzer intended for single-use or reusable applications, and how should I determine which configuration to use?
The EasyLyte Calcium Analyzer can be used with either single-use or reusable electrode modules, depending on the specific module selected. The manufacturer’s guidelines should be consulted to determine the appropriate configuration for your workflow, as this depends on factors like cost efficiency, infection control protocols, and sample volume.
What storage and maintenance requirements should I follow for the EasyLyte Calcium Analyzer to ensure optimal performance?
The analyzer requires adherence to the manufacturer’s guidelines for storage and maintenance, though specific details like temperature ranges or cleaning protocols are not provided in the data. Since it is not MRI-safe, it must also be stored and used in environments where magnetic resonance imaging is not a concern. Always refer to Medica Corp.’s instructions for proper handling.
How was the regulatory pathway for the EasyLyte Calcium Analyzer determined, and what does this mean for its use in clinical settings?
The device was cleared through the FDA’s 510(k) process with a *Traditional* clearance type, classified under Device Class 2 (regulation number 862.1145). This means it was determined to be *substantially equivalent* to a predicate device already on the market, ensuring it meets established safety and performance standards for clinical chemistry applications. The clearance does not imply any specific clinical indication but confirms its suitability for measuring calcium ions in biological samples.
Are there multiple models or variations of the EasyLyte Calcium Analyzer, and how can I identify the correct one for my lab?
The data lists multiple *FEI numbers* (e.g., 3005643513, 3014506106) associated with the EasyLyte Calcium Analyzer, which may correspond to different electrode modules or configurations. While the exact differences between these variations are not detailed, the *product code (JFP)* and *advisory committee classification (Clinical Chemistry)* suggest these are related variants of the same core analyzer. Contact Medica Corp. or refer to their documentation to confirm compatibility with your lab’s workflow.
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: EasyLyte - Electrolyte analyzer - Medica Corporation, Electrolyte analyzer - EasyLyte - EasyElectrolytes - Medica Corporation, Medica EasyLyte Electrolyte Analyzers - medical-xprt.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K943091 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K943091 24 fields · synced Sep 20, 2026