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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k113614 B. Purpose for Submission: New blood glucose monitoring system combining
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How to fill out new blood glucose monitoring
How to fill out new blood glucose monitoring:
01
Gather all the necessary supplies: A blood glucose monitor, test strips, a lancet device, lancets, alcohol wipes, and a logbook.
02
Wash your hands thoroughly with soap and warm water. Dry them well.
03
Turn on the blood glucose monitor and make sure it is functioning properly.
04
Insert a new test strip into the monitor as per the manufacturer's instructions.
05
Use the lancet device to prick the side of your fingertip gently. Squeeze the fingertip to produce a small drop of blood.
06
Touch the tip of the test strip to the droplet of blood, allowing it to be drawn into the strip.
07
Wait for the blood glucose monitor to display the result. Record the result in your logbook.
08
Dispose of the lancet in a sharps container and discard any used test strips.
09
Repeat this process as directed by your healthcare provider.
10
Remember to clean the blood glucose monitor regularly according to the manufacturer's instructions.
Who needs new blood glucose monitoring:
01
Individuals with diabetes or prediabetes who need to monitor their blood glucose levels regularly.
02
People who are starting a new medication or treatment that may affect blood glucose levels.
03
Pregnant women with gestational diabetes who need to monitor their blood glucose levels to manage their condition.
04
Athletes or individuals with specific dietary or fitness goals who want to track how their blood sugar is affected by exercise or certain foods.
05
People with a family history of diabetes or other risk factors for the disease who want to proactively monitor their blood glucose levels for early detection.
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What is new blood glucose monitoring?
New blood glucose monitoring refers to the process of regularly measuring and tracking blood sugar levels to manage diabetes.
Who is required to file new blood glucose monitoring?
Individuals with diabetes or their caregivers are required to file new blood glucose monitoring.
How to fill out new blood glucose monitoring?
To fill out new blood glucose monitoring, individuals need to regularly test their blood sugar levels using a glucose meter and record the results in a logbook or digital app.
What is the purpose of new blood glucose monitoring?
The purpose of new blood glucose monitoring is to help individuals with diabetes track and manage their blood sugar levels to prevent complications and improve overall health.
What information must be reported on new blood glucose monitoring?
New blood glucose monitoring should include details such as date, time of day, blood sugar level, medications taken, and any notes about food or physical activity.
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