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rfa-300 rapid flow analyzer w computer
Alpkem
Summary: The RFA-300 Rapid Flow Analyzer by Alpkem is a medical device used for rapid analysis of fluid samples, primarily in laboratory settings. It is typically used by laboratory technicians and clinicians for diagnostic purposes.
FDA Clearance Information
Pathway
510K
Number
K883020 ↗
Decision Date
September 2, 1988
Product Code
JJF
Device Class
Class 1
Evidence
0 studies
The RFA-300 was cleared through the FDA 510k pathway on September 2, 1988. Manufactured by Alpkem, it is classified as a Class 1 device under the product code JJF.
What It Is
The RFA-300 Rapid Flow Analyzer is a laboratory device designed to quickly analyze fluid samples. It operates by measuring the flow of fluids through a system, providing rapid results that are essential for timely diagnostics. This device is particularly useful in settings where quick turnaround times are critical, such as in emergency departments or specialized diagnostic labs.
Clinical Applications
The RFA-300 is commonly used in clinical laboratories for the analysis of blood, urine, and other bodily fluids. It is particularly valuable in hospital labs, research institutions, and clinics where rapid diagnostic results are necessary. The device supports various specialties, including pathology, internal medicine, and emergency medicine, by providing quick and reliable data for patient management.
Indications for Use
The FDA-cleared indications for the RFA-300 involve its use in analyzing fluid samples to aid in diagnostic processes. It is suitable for patients requiring rapid diagnostic testing, such as those in acute care settings.
Practical Considerations
The RFA-300 is typically compatible with standard laboratory equipment and requires minimal setup. It is important for users to be familiar with its operation to ensure accurate results. Regular maintenance and calibration are recommended to maintain its precision and reliability.
Frequently Asked Questions
What is the RFA-300 Rapid Flow Analyzer used for?
The RFA-300 is used for rapid analysis of fluid samples in clinical laboratory settings.
What specialties typically use this device?
Specialties such as pathology, internal medicine, and emergency medicine commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in analyzing fluid samples to aid in diagnostics, particularly in settings requiring rapid results.
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.