SmartLyte Electrolyte Analyzer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121040 FDA 510(k)
- FDA Product Code
- CEM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1600 FDA 510(k)
- Regulation Number
- 862.1600 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SmartLyte Electrolyte Analyzer is an Ion Specific Electrode designed for clinical chemistry applications. It measures sodium (Na+), potassium (K+), chloride (Cl-), calcium (Ca++), and lithium (Li+) concentrations in whole blood, serum, plasma, and urine using Ion Selective Electrode (ISE) technology.
This automated system is intended for use in clinical laboratory settings. It operates as a single-use or reusable device (as applicable to consumables) and adheres to FDA 510(k) clearance and IVDR regulatory standards. The analyzer is classified under Device Class II and includes multiple FEI numbers for regulatory tracking. Storage and handling follow standard laboratory protocols for electrochemical analyzers.
Frequently asked questions
What types of samples can the SmartLyte Electrolyte Analyzer measure, and how does it determine electrolyte concentrations?
The SmartLyte Electrolyte Analyzer measures sodium (Na+), potassium (K+), chloride (Cl-), calcium (Ca++), and lithium (Li+) concentrations in whole blood, serum, plasma, and urine using Ion Selective Electrode (ISE) technology. This method allows precise detection of ion concentrations by leveraging the device’s specialized electrodes, which respond selectively to each electrolyte in the sample.
Is the SmartLyte Electrolyte Analyzer designed for single-use or reusable consumables, and how does this affect workflow?
The SmartLyte Electrolyte Analyzer supports both single-use and reusable consumables, depending on the specific components (e.g., electrodes or probes) used. This flexibility allows laboratories to choose between disposable electrodes for convenience and reduced contamination risk or reusable electrodes for cost efficiency, provided proper cleaning and maintenance protocols are followed.
What regulatory pathways does the SmartLyte Electrolyte Analyzer follow, and how does this impact its use in clinical settings?
The device is cleared under FDA 510(k) (K121040) and complies with IVDR (In Vitro Diagnostic Regulation) standards, classifying it as a Class II medical device under regulatory oversight. This means it undergoes rigorous validation for clinical chemistry applications and adheres to strict manufacturing and performance requirements, ensuring reliability for electrolyte measurements in accredited laboratories.
How should the SmartLyte Electrolyte Analyzer be stored, and are there any special handling instructions for maintaining accuracy?
Storage follows standard laboratory protocols for electrochemical analyzers, though specific details like temperature, humidity, and protection from light are implied. Since it’s designed for clinical chemistry use, it should be stored in a clean, controlled environment to prevent contamination or damage to the ISE electrodes. Always refer to the manufacturer’s instructions for precise storage guidelines, particularly if reusable components are involved.
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: SmartLyte® Plus | Electrolyte Analyzer | Diamond Diagnostics, Diamond SmartLyte Plus | Electrolyte Analyzers - Diamond Diagnostics, Automated electrolyte analyzer - Smartlyte® Plus - Diamond Diagnostics ..., Diamond Smartlyte - Model Plus - Electrolyte Analyzer
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K121040 | Class II | Active |
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Manufacturer
- Manufacturer
- DIAMOND DIAGNOSTICS Inc
- FDA Applicant
- Diamond Diagnostics, Inc.
Sources (2)
- FDA 510(k) K121040 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026