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Nova 13 Analyzer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K924864

by Nova Biomedical Corp.

Identifiers

510(k) Number
K924864 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 Nova 13 Analyzer is an Electrode, Ion-Specific, Chloride, designed for precise measurement of chloride ion concentrations in clinical chemistry applications. It operates as a standalone analyzer, utilizing ion-selective electrodes to deliver accurate and rapid results for patient monitoring and diagnostic purposes.

This device is intended for use in clinical laboratories and point-of-care settings, supplied as a reusable instrument requiring proper maintenance and calibration. It is not sterile and must be cleaned and disinfected according to manufacturer guidelines. The analyzer is classified under FDA regulation 862.1170 and holds a 510(k) clearance (K924864) for substantial equivalence in clinical chemistry applications. No MRI safety information is specified.

Frequently asked questions

What is the Nova 13 Analyzer designed for?

The Nova 13 Analyzer is specifically designed for precise measurement of chloride ion concentrations in clinical chemistry applications. It uses ion-selective electrodes to deliver accurate and rapid results, making it suitable for patient monitoring and diagnostic purposes in clinical laboratories and point-of-care environments.

Is the Nova 13 Analyzer reusable or single-use?

The Nova 13 Analyzer is a reusable instrument. It requires proper maintenance, calibration, and cleaning according to the manufacturer’s guidelines to ensure accurate and reliable performance over time.

Does the Nova 13 Analyzer come sterile?

No, the Nova 13 Analyzer is not supplied sterile. It is intended for use in clinical settings where it must be cleaned and disinfected between uses to maintain hygiene and functionality.

What regulatory clearance does the Nova 13 Analyzer hold?

The Nova 13 Analyzer holds a 510(k) clearance (K924864) from the FDA, demonstrating substantial equivalence in clinical chemistry applications under regulation 862.1170. This clearance confirms its compliance with U.S. regulatory standards for ion-specific chloride measurement devices.

How should the Nova 13 Analyzer be stored?

The Nova 13 Analyzer should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Follow the manufacturer’s instructions for proper storage to preserve its functionality and ensure longevity, including any specific guidelines for calibration and maintenance.

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 13 ANALYZER, MODIFICATION (K924864) — FDA 510 (k) | Innolitics, NOVA 13 ANALYZER, MODIFICATION 510 (k) K924864 - FDA.report, PDF K924864 - Nova 13 Analyzer, Modification, Nova Biomedical Product Documentation - Blood Gas Analyzers and Glucose ..., Nova Biomedical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nova Biomedical Corp.

Sources (1)

  • FDA 510(k) K924864 24 fields · synced Oct 1, 2026