EasyElectrolyte Analyzer and Rapidlyte Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K000926 FDA 510(k)
- FDA Product Code
- CGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1170 FDA 510(k)
- Regulation Number
- 862.1170 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyElectrolyte Analyzer and Rapidlyte Analyzer is an Ion-Specific Electrode, designed for the quantitative measurement of electrolytes such as sodium (Na+), potassium (K+), chloride (Cl-), and lithium (Li+). This device operates by utilizing ion-selective electrodes to detect and analyze electrolyte concentrations in biological samples, including whole blood, serum, urine, and plasma. It provides rapid and accurate results, supporting clinical chemistry applications in laboratory settings.
The analyzer is supplied as a reusable medical device intended for use in clinical chemistry laboratories. It requires calibration and maintenance as specified by the manufacturer, with results delivered promptly to assist in patient diagnosis and monitoring. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance under the Traditional pathway. Storage and handling follow standard laboratory protocols to ensure accuracy and reliability of measurements.
Frequently asked questions
What types of biological samples can the EasyElectrolyte Analyzer and Rapidlyte Analyzer measure for electrolyte levels?
The device is designed to quantitatively measure electrolytes—such as sodium (Na+), potassium (K+), chloride (Cl-), and lithium (Li+)—in whole blood, serum, urine, and plasma samples. This versatility supports clinical chemistry applications across various patient monitoring scenarios.
Is the EasyElectrolyte Analyzer and Rapidlyte Analyzer a single-use or reusable device, and what maintenance does it require?
The analyzer is a reusable medical device intended for use in clinical chemistry laboratories. It requires calibration and routine maintenance as specified by Medica Corp. to ensure accurate and reliable electrolyte measurements over time.
How quickly does the device provide results, and what clinical setting is it intended for?
The device is designed to deliver rapid and accurate electrolyte measurements, supporting prompt clinical decision-making in laboratory settings. It is specifically intended for use in clinical chemistry laboratories to assist with patient diagnosis and monitoring.
What regulatory pathway was followed for FDA clearance of the EasyElectrolyte Analyzer and Rapidlyte Analyzer?
The device received FDA 510(k) clearance under the Traditional pathway, demonstrating that it is substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under FDA regulations.
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: Electrolyte analyzer - EasyLyte - EasyElectrolytes - Medica Corporation, EasyElectrolytes - Electrolyte analyzer - Medica Corporation, EasyElectrolytes - Medica Corp. - PDF Catalogs - MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K000926 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K000926 24 fields · synced Sep 20, 2026