EasyLyte Sodium/Potassium/Lithium Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K914810 FDA 510(k)
- FDA Product Code
- JGS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1665 FDA 510(k)
- Regulation Number
- 862.1665 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyLyte Sodium/Potassium/Lithium Analyzer is an ion-specific electrode device designed for measuring sodium (Na+), potassium (K+), and lithium (Li+) concentrations in biological samples. It employs ion-selective electrode (ISE) technology to provide precise electrolyte analysis, supporting clinical chemistry applications in laboratory settings.
This analyzer is intended for use in clinical chemistry laboratories, processing whole blood, serum, plasma, or urine samples. Supplied as a reusable instrument, it requires appropriate maintenance and calibration. The device is classified as Class II under FDA regulations and holds a 510(k) clearance for traditional review, with an advisory committee classification in Clinical Chemistry. Storage and handling follow standard laboratory protocols for electrochemical analyzers.
Frequently asked questions
What types of biological samples can the EasyLyte Sodium/Potassium/Lithium Analyzer analyze?
The EasyLyte Sodium/Potassium/Lithium Analyzer is designed to measure sodium (Na+), potassium (K+), and lithium (Li+) concentrations in whole blood, serum, plasma, and urine samples. This versatility makes it suitable for a wide range of clinical chemistry applications, including electrolyte monitoring and diagnostic testing.
Is the EasyLyte Sodium/Potassium/Lithium Analyzer a single-use or reusable device?
The EasyLyte Sodium/Potassium/Lithium Analyzer is a reusable instrument. As a reusable device, it requires regular maintenance, calibration, and adherence to standard laboratory protocols to ensure accurate and reliable performance over time.
What kind of maintenance does the EasyLyte Sodium/Potassium/Lithium Analyzer require?
Since the EasyLyte Sodium/Potassium/Lithium Analyzer is a reusable electrochemical analyzer, it requires routine maintenance such as electrode cleaning, calibration checks, and periodic inspection of its components. Following the manufacturer’s guidelines for storage and handling—such as avoiding contamination and extreme temperatures—is essential to maintain its performance and longevity.
How is the sterility of the EasyLyte Sodium/Potassium/Lithium Analyzer ensured?
The EasyLyte Sodium/Potassium/Lithium Analyzer itself is not a sterile device, as it is designed for reusable use in clinical chemistry laboratories. Sterility in this context applies to the samples being tested (whole blood, serum, plasma, or urine) rather than the analyzer hardware. Laboratories must follow standard aseptic techniques when handling samples to prevent contamination.
What regulatory pathway does the EasyLyte Sodium/Potassium/Lithium Analyzer follow?
The EasyLyte Sodium/Potassium/Lithium Analyzer holds a 510(k) clearance from the FDA under traditional review, classified as a Class II device. It was submitted to the Clinical Chemistry (CH) advisory committee for review and is intended for use in clinical chemistry laboratories. The device’s regulatory classification reflects its role in precise electrolyte measurement.
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 Analyzer User Manual | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914810 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K914810 24 fields · synced Oct 1, 2026