Stat Profile Prime Plus Analyzer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200204 FDA 510(k)
- FDA Product Code
- GGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7500 FDA 510(k)
- Regulation Number
- 864.7500 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stat Profile Prime Plus Analyzer System is a whole blood critical care analyzer designed for rapid hematological and biochemical testing. It performs quantitative measurements of key parameters such as oxyhemoglobin, pH, and other critical care markers, supporting clinical decision-making in acute care settings. Classified under the Hematology medical specialty, it is intended for use in clinical laboratories and point-of-care environments. The device operates with a 24-test panel, enabling comprehensive monitoring of patient status in critical conditions.
This analyzer system is supplied as a traditionally cleared medical device under FDA 510K clearance (K200204) and falls under Device Class II. It is intended for single-use or reusable components, depending on the specific consumables and accessories used. The system is not explicitly noted for MRI safety in the provided data. Storage and handling follow standard clinical laboratory protocols, with maintenance requirements noted as ‘maintenance-free’ for the core analyzer unit. No additional regulatory markings or sterility claims are specified beyond its FDA clearance.
Frequently asked questions
What clinical specialties and settings use the Stat Profile Prime Plus Analyzer System?
The Stat Profile Prime Plus Analyzer System is designed for use in hematology, supporting clinical laboratories and point-of-care environments. It is specifically intended for acute care settings where rapid, comprehensive monitoring of patient status is critical, such as emergency departments, intensive care units, or surgical recovery areas. Its 24-test panel enables simultaneous assessment of key parameters like oxyhemoglobin and pH, aiding clinical decision-making in time-sensitive scenarios.
How is the Stat Profile Prime Plus Analyzer System supplied, and what are its key components?
The system is supplied as a traditionally cleared medical device under FDA 510K clearance (K200204). It includes a core analyzer unit, which is noted as maintenance-free, along with consumables and accessories that may be either single-use or reusable, depending on the specific part. The analyzer operates independently of additional third-party systems, though compatibility with standard clinical laboratory infrastructure is assumed for integration.
Does the Stat Profile Prime Plus Analyzer System require sterility, and how should it be stored?
The provided data does not explicitly specify sterility claims beyond its FDA clearance. However, as a device intended for whole blood testing in critical care, it should adhere to standard clinical laboratory protocols for storage and handling. The core analyzer unit is designed for durability, but consumables (e.g., test cartridges or sample cups) should follow manufacturer guidelines for cleanliness, contamination prevention, and environmental conditions (e.g., temperature, humidity) to ensure accuracy and reliability.
What types of tests does the Stat Profile Prime Plus Analyzer System perform, and why is this important?
The system performs quantitative measurements of 24 critical care parameters, including oxyhemoglobin, pH, and other hematological/biochemical markers. This capability is vital for rapid, simultaneous assessment of a patient’s physiological status in acute conditions, such as trauma, sepsis, or respiratory failure. By providing comprehensive data quickly, clinicians can make time-sensitive interventions, such as adjusting oxygen therapy or transfusions, thereby improving patient outcomes in high-risk scenarios.
Is the Stat Profile Prime Plus Analyzer System safe for use in environments with MRI equipment?
The provided data does not explicitly state MRI safety for the Stat Profile Prime Plus Analyzer System. If used in proximity to MRI machines, clinicians should verify compatibility with the manufacturer’s guidelines or consult technical specifications to avoid interference or safety risks. Standard clinical protocols for non-MRI-safe devices should be followed unless confirmed otherwise by Nova Biomedical Corporation.
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 - Wiley Online Library, Stat Profile Prime Plus® Comprehensive Critical Care Analyzer, Stat Profile® | Nova Biomedical, PDF Instructions for Use Manual - 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 | K200204 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA 510(k) K200204 24 fields · synced Oct 1, 2026