Stat Profile Prime Plus Analyzer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180340 FDA 510(k)
- FDA Product Code
- CGA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stat Profile Prime Plus Analyzer System is a critical care analyzer designed for the quantitative determination of pH, partial pressure of carbon dioxide, and partial pressure of oxygen. It is intended for use by healthcare professionals in clinical laboratory settings and for point-of-care testing.
This device is authorized via FDA 510K clearance. It is designed for use with whole blood samples and is intended for professional use within clinical environments.
Frequently asked questions
What is the primary purpose of the Stat Profile Prime Plus Analyzer System?
This device is a critical care analyzer intended for the quantitative determination of pH, partial pressure of carbon dioxide, and partial pressure of oxygen in whole blood samples.
Who is the intended user for this analyzer system?
The system is designed for professional use by healthcare personnel within clinical laboratory settings and for point-of-care testing environments.
What is the regulatory status of this device?
The Stat Profile Prime Plus Analyzer System is authorized for use via FDA 510K clearance, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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 Plus® Comprehensive Critical Care Analyzer, Stat Profile® | Nova Biomedical, PDF Instructions for Use Manual - novabiomedicaldocs.com, 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 | K180340 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA 510(k) K180340 24 fields · synced Sep 27, 2026