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This document serves as a summary of the 510(k) premarket notification submitted to the FDA for the Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System, detailing its intended use, technological
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How to fill out 510k summary - precision
How to fill out 510(k) Summary - Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System
01
Determine the device classification and confirm if it requires a 510(k) submission.
02
Gather all relevant information about the Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System, including product specifications and intended use.
03
Review FDA guidelines for 510(k) submissions to ensure compliance with required formats and content.
04
Provide a detailed description of the device, including its design, materials, and technology used.
05
Include performance data demonstrating that the device is safe and effective for its intended use, comparing it to predicate devices if applicable.
06
Outline the proposed labeling and instructions for use, ensuring they meet FDA requirements.
07
Submit the 510(k) application along with the required fee to the FDA and respond to any additional information requests.
Who needs 510(k) Summary - Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System?
01
Manufacturers of the Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System seeking market entry in the USA.
02
Healthcare professionals and clinics intending to use the device for patient glucose and ketone monitoring.
03
Regulatory affairs specialists involved in compliance and submissions for medical devices.
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People Also Ask about
How do you read ketones on a glucose meter?
5 Your results will fall into one of the following three ranges: Below 0.6 mmol/L: If your reading is below 0.6 you are in the normal range. 0.6 to 1.5 mmol/L: This level is above the normal range. Above 1.5 mmol/L: Readings above 1.5 indicate a greater risk for developing ketoacidosis.
What is a normal ketone level in blood sugar?
Checking your blood glucose and ketones under 0.6mmol/L is normal. 0.6 to 1.5mmol/L is slightly high – test again in 2 hours. 1.6 to 3mmol/L means you're at risk of DKA and should speak to your diabetes care team for advice. over 3mmol/L is high and means you may have DKA and should call 999 or go to A&E.
What is the test time of the freestyle precision pro ketone test strip?
The result, date and time are displayed after a 10 second countdown. displayed as > 8.0mmol/l. Remove the test strip from the test strip port and dispose of appropriately.
What should my glucose ketone index be?
The zone of metabolic management is likely entered with GKI values between 1 and 2 for humans. Optimal management is predicted for values approaching 1.0, and blood glucose and ketone values should be measured 2–3 hours postprandial, twice a day if possible.
How to read ketones on a glucose meter?
5 Your results will fall into one of the following three ranges: Below 0.6 mmol/L: If your reading is below 0.6 you are in the normal range. 0.6 to 1.5 mmol/L: This level is above the normal range. Above 1.5 mmol/L: Readings above 1.5 indicate a greater risk for developing ketoacidosis.
What is the assay range of the freestyle β ketone test strip?
Measuring limits are 1.1 – 27.8mmol/L for glucose and 0.0 – 8.0mmol/L for ketones. Outside of these values a greater than (>) or less than (<) sign will be displayed.
Can glucose meter measure ketones?
The Freestyle Libre Flash Glucose Monitoring reader can also be used to check finger BGLs and blood ketones. To help manage your data, all the meters allow you to quickly and conveniently transfer your glucose and ketone levels via Bluetooth to a compatible smartphone.
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What is 510(k) Summary - Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System?
The 510(k) Summary for the Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System is a document submitted to the FDA that provides evidence that the device is safe and effective for its intended use. It summarizes the product's description, technology, and performance data.
Who is required to file 510(k) Summary - Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System?
Manufacturers or importers of the Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System are required to file a 510(k) Summary with the FDA before marketing the device.
How to fill out 510(k) Summary - Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System?
To fill out the 510(k) Summary, manufacturers should provide detailed information including the device description, indications for use, substantial equivalence comparisons to other devices, labeling, and performance testing results.
What is the purpose of 510(k) Summary - Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System?
The purpose of the 510(k) Summary is to demonstrate to the FDA that the Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System is safe and effective for its intended uses and is substantially equivalent to legally marketed devices.
What information must be reported on 510(k) Summary - Precision Xceed Pro Blood Glucose and β-Ketone Monitoring System?
Information required includes the device name, intended use, technological characteristics, performance data, labeling, and any clinical data if applicable.
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