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rfa 2 rapid flow analyzer w computer
Alpkem
Summary: The RFA 2 Rapid Flow Analyzer by Alpkem is an FDA-cleared device used for rapid flow analysis in clinical settings. It is primarily utilized by laboratory technicians and clinicians for analyzing fluid samples.
FDA Clearance Information
Pathway
510K
Number
K890332 ↗
Decision Date
February 17, 1989
Product Code
JJC
Device Class
Class 1
Evidence
0 studies
The RFA 2 Rapid Flow Analyzer was cleared through the FDA 510(k) pathway on February 17, 1989. Manufactured by Alpkem, it is classified as a Class 1 device under product code JJC.
What It Is
The RFA 2 Rapid Flow Analyzer is a laboratory instrument designed to perform rapid flow analysis of fluid samples. It integrates with a computer system to provide precise and efficient analysis, making it a valuable tool in clinical laboratories. The device is used to measure various parameters in biological samples, aiding in diagnostic and research applications.
Clinical Applications
This device is commonly used in clinical laboratories for analyzing blood, urine, and other bodily fluids. It is particularly useful in settings where quick and accurate analysis is required, such as in hospitals and diagnostic centers. Laboratory technicians and clinical pathologists frequently use this device to support patient diagnosis and management.
Indications for Use
The FDA indications for the RFA 2 Rapid Flow Analyzer involve its use in analyzing fluid samples for various diagnostic purposes. It is suitable for patients requiring laboratory analysis of blood or other bodily fluids to aid in diagnosis and treatment planning.
Practical Considerations
The RFA 2 Rapid Flow Analyzer typically requires standard laboratory space and is compatible with common laboratory software systems. Users should ensure proper calibration and maintenance for accurate results. Training on the specific software interface may be necessary for optimal use.
Related Literature
The linked study, titled 'Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures,' explores the impact of nicotine reduction on electronic nicotine delivery systems (ENDS) users. While the abstract is not available, the study likely examines addiction levels and exposure metrics. Limitations may include a lack of detailed methodology and participant demographics.
Frequently Asked Questions
What is the RFA 2 Rapid Flow Analyzer used for?
It is used for rapid flow analysis of fluid samples in clinical laboratories.
What specialties typically use this device?
Clinical pathologists and laboratory technicians in hospital and diagnostic laboratory settings.
What are the FDA-cleared indications?
The device is indicated for use in analyzing fluid samples for diagnostic purposes.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.