Nova 2 Ionized Calcium Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K771643 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 Nova 2 Ionized Calcium Analyzer is an Electrode, Ion Specific, Calcium, designed for precise measurement of ionized calcium levels in clinical samples. As a Class II device, it employs ion-selective electrode technology to provide accurate and rapid analysis, supporting diagnostic assessments in clinical chemistry.
This analyzer is intended for use in clinical laboratory settings and has received FDA 510(k) clearance under the Traditional pathway, classified under regulation 862.1145. It is supplied as a reusable device and requires proper calibration and maintenance as specified in its operational manual. The device is regulated under the Clinical Chemistry specialty and is not intended for MRI use.
Frequently asked questions
What clinical setting is the Nova 2 Ionized Calcium Analyzer designed for, and why is this important for potential buyers?
The Nova 2 Ionized Calcium Analyzer is specifically designed for use in clinical laboratory settings, where precise ionized calcium measurements are critical for diagnostic assessments in clinical chemistry. This distinction is important for buyers because it ensures the device is intended for controlled, professional environments where calibration, maintenance, and adherence to laboratory protocols are standard practices. It is not intended for point-of-care or home use, which helps clinicians and lab managers select the appropriate tool for their workflow.
Is the Nova 2 Ionized Calcium Analyzer a single-use or reusable device, and what does this mean for maintenance and cost considerations?
The Nova 2 Ionized Calcium Analyzer is a reusable device, meaning it is built to be used repeatedly after proper cleaning, calibration, and maintenance as outlined in its operational manual. This design impacts cost considerations because while the initial purchase price may be higher, the long-term expense is offset by avoiding disposable costs. However, buyers should account for routine upkeep, including electrode replacement and calibration checks, to ensure accuracy and longevity of the device.
What regulatory pathway was followed for FDA clearance of the Nova 2 Ionized Calcium Analyzer, and how does this affect its use in clinical settings?
The Nova 2 Ionized Calcium Analyzer received FDA 510(k) clearance under the Traditional pathway, which means it was determined to be substantially equivalent to a previously cleared device in its category (Electrode, Ion Specific, Calcium). This pathway ensures that the device meets established safety and performance standards for clinical chemistry applications. Clinicians and labs can rely on this clearance to confirm the device’s regulatory compliance, though they should always follow manufacturer guidelines and local regulatory requirements for its use.
Does the Nova 2 Ionized Calcium Analyzer have any restrictions on its use, such as compatibility with MRI environments?
The Nova 2 Ionized Calcium Analyzer is not intended for MRI use, as explicitly stated in its description. This means it should not be placed in or near MRI environments, as the device’s materials or components may not be MRI-safe. Buyers, particularly those in hospitals or multi-specialty clinics, should ensure proper placement away from MRI rooms to avoid potential interference or safety risks.
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 2 IONIZED CALCIUM ANALYZER 510 (k) K771643 - FDA.report, PDF K771643 - Nova 2 Ionized Calcium Analyzer, Measurement of ionized calcium using the Nova 2 analyser, Nova Biomedical, Stat Profile® Prime ES Electrolyte Analyzer | Nova Biomedical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771643 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K771643 24 fields · synced Sep 19, 2026