Nova Stat Profile Prime CCS Analyzer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131703 FDA 510(k)
- FDA Product Code
- CHL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1120 FDA 510(k)
- Regulation Number
- 862.1120 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nova Stat Profile Prime CCS Analyzer System is an electrode measurement device for blood gases (PCO₂, PO₂), blood pH, and related clinical chemistry parameters. It performs automated electrochemical and photometric assays on whole blood to measure critical analytes, including electrolytes and key metabolites, enabling rapid diagnostic evaluation in acute care settings. Designed for clinical chemistry applications, it provides real-time monitoring of arterial blood gases, acid-base balance, and metabolic status to support patient management in critical care environments.
This system is intended for use in clinical laboratories and point-of-care settings, where it is operated by trained personnel. Supplied as a reusable, non-sterile instrument, it requires calibration and maintenance according to manufacturer guidelines. The device is FDA-cleared under 510(k) K131703 and classified as a Class II medical device under regulation 21 CFR 862.1120. It operates in non-MRI environments and includes disposable MicroSensor Cards for sample analysis. Storage and handling follow standard laboratory protocols to ensure accuracy and reliability.
Frequently asked questions
What clinical parameters does the Nova Stat Profile Prime CCS Analyzer System measure?
The Nova Stat Profile Prime CCS Analyzer System performs automated electrochemical and photometric assays on whole blood to measure critical analytes including arterial blood gases (PCO₂, PO₂), blood pH, electrolytes, and key metabolites. These measurements enable real-time monitoring of acid-base balance and metabolic status, supporting patient management in acute and critical care settings.
Is the Nova Stat Profile Prime CCS Analyzer System reusable or single-use?
The Nova Stat Profile Prime CCS Analyzer System is designed as a reusable instrument. It requires calibration and maintenance according to the manufacturer’s guidelines to ensure accurate and reliable performance over time. Disposable MicroSensor Cards are used for each sample analysis.
What type of environment is the Nova Stat Profile Prime CCS Analyzer System intended for?
This system is intended for use in clinical laboratories and point-of-care settings, where it is operated by trained personnel. It is not designed for MRI environments and must be used in non-MRI-compatible areas. The device is suitable for acute care environments where rapid diagnostic evaluation is critical.
How are samples analyzed on the Nova Stat Profile Prime CCS Analyzer System?
The system uses disposable MicroSensor Cards for sample analysis. These cards interface with the reusable analyzer to perform electrochemical and photometric assays on whole blood, enabling automated and rapid measurement of blood gases, pH, electrolytes, and metabolites without manual intervention.
What regulatory status does the Nova Stat Profile Prime CCS Analyzer System hold?
The device is FDA-cleared under 510(k) K131703 and classified as a Class II medical device under regulation 21 CFR 862.1120. It is also registered under multiple FEI numbers for clinical chemistry applications, reflecting its intended use in diagnostic testing.
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: Stat Profile® Prime CCS Critical Care Analyzer | Nova Biomedical, Stat Profile Prime® CCS Comp - Nova Biomedical, NOVA BIOMEDICAL Stat Profile PRIME Instructions For Use Manual, PDF Stat Profile PRIME CCS Analyzer - novabiomedicaldocs.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131703 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA 510(k) K131703 24 fields · synced Oct 1, 2026