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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k101299 B. Purpose for Submission: New blood glucose monitoring system (new
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How to fill out new blood glucose monitoring
How to fill out new blood glucose monitoring:
01
First, gather all necessary supplies for blood glucose monitoring, including a new blood glucose meter, lancets, test strips, and an alcohol swab.
02
Make sure your hands are clean before beginning the process. Wash them thoroughly with soap and warm water, or use an alcohol-based hand sanitizer.
03
Prepare the lancet device by inserting a new lancet into it. Adjust the depth setting on the device according to your comfort level, typically a shallower setting for those with sensitive skin.
04
Choose a finger to prick for the blood sample. It's recommended to rotate fingers to minimize discomfort and potential skin damage. Clean the chosen finger with an alcohol swab and let it air dry.
05
Insert the lancet device against the side of the clean finger and push the button to prick it. Allow a small drop of blood to form on the puncture site.
06
Turn on the new blood glucose meter and prepare the test strip by inserting it into the designated slot or port. Wait for the meter to indicate that it is ready for the blood sample.
07
Gently touch the tip of the test strip to the blood droplet on your finger. The strip will automatically draw in the blood sample. Some meters may require you to apply the blood sample directly to the strip instead.
08
Wait for the meter to process the blood sample. This typically takes a few moments, during which the meter will display a countdown or a progress indicator.
09
Once the blood glucose reading appears on the meter's display, record the result in a logbook or on a digital device, if desired. You may also take note of the date and time if necessary.
Who needs new blood glucose monitoring:
01
Individuals diagnosed with diabetes, both type 1 and type 2, typically require blood glucose monitoring. This is crucial for managing their blood sugar levels and making informed decisions about their diet, medication, and physical activity.
02
Pregnant women with gestational diabetes often need blood glucose monitoring to ensure their blood sugar levels are kept within a safe range for both their health and the health of the unborn baby.
03
People who are at risk of developing diabetes, such as individuals with a family history of the condition or those who are overweight, may benefit from regular blood glucose monitoring to detect any potential signs of prediabetes or early-stage diabetes.
04
Individuals with certain medical conditions, such as pancreatitis or hormonal disorders, may also require blood glucose monitoring to assess their body's ability to regulate blood sugar levels effectively.
Note: It is vital to consult with a healthcare professional who can provide personalized guidance on blood glucose monitoring and its significance based on individual health needs.
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