Nova Nucleus Clinical Chemical Syst, Modification
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K921937 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 Nova Nucleus Clinical Chemistry System, Modification is an Electrode, Ion Specific, Sodium, designed for the quantitative measurement of sodium ion concentrations in clinical specimens. This device operates within clinical chemistry laboratories to provide accurate and reliable results for patient monitoring and diagnostic purposes, supporting assessments of electrolyte balance and metabolic function.
This system is intended for use in clinical laboratory settings and is supplied as a reusable medical device. It adheres to FDA regulatory standards under 510(k) clearance K921937 and falls under the classification of Device Class II (862.1665). The system is not single-use and requires proper maintenance, calibration, and storage as outlined in manufacturer guidelines to ensure accurate performance. No specific MRI safety information is provided, and its use is governed by clinical chemistry protocols.
Frequently asked questions
What is the Nova Nucleus Clinical Chemistry System, Modification used for?
The Nova Nucleus Clinical Chemistry System, Modification is designed specifically for the quantitative measurement of sodium ion concentrations in clinical specimens. This helps clinicians monitor electrolyte balance and assess metabolic function, which is critical for diagnosing conditions like dehydration, kidney disease, or metabolic disorders. It operates within clinical chemistry laboratories to provide reliable results for patient care.
Is the Nova Nucleus Clinical Chemistry System single-use or reusable?
The Nova Nucleus Clinical Chemistry System is a reusable medical device. It requires proper maintenance, calibration, and storage as outlined by the manufacturer to ensure consistent accuracy and performance over time. Reusability helps reduce waste and operational costs in clinical settings.
What maintenance or storage requirements does the system have?
The system must be maintained according to the manufacturer’s guidelines, which include regular calibration and cleaning procedures to ensure accurate sodium ion measurements. Storage should follow the provided instructions to prevent contamination or damage, as improper storage could compromise performance and reliability. Always refer to Nova Biomedical Corp.’s documentation for specific protocols.
Does the Nova Nucleus Clinical Chemistry System have any special handling instructions for sterility?
The device is not described as single-use, so sterility is not a primary concern for individual electrodes. However, reusable components must be cleaned and disinfected between uses to prevent cross-contamination. The manufacturer’s instructions detail proper disinfection and maintenance procedures to ensure safe and accurate operation in clinical settings.
What regulatory approval does the Nova Nucleus Clinical Chemistry System hold?
The Nova Nucleus Clinical Chemistry System, Modification holds FDA 510(k) clearance under the reference number K921937. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and meets FDA regulatory standards for clinical chemistry systems. Always verify compliance with current regulations before use.
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: Nova Nucleus Clinical Chemical Syst, Modification, NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION… - FDA.report, Nova Biomedical, NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM - Innolitics, Safety Data Sheets (SDS) - Nova Biomedical Product Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K921937 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K921937 24 fields · synced Oct 1, 2026