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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k153278 B. Purpose for Submission: Modified devices to add compatibility with

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How to fill out capillary whole blood glucose

01

Wash your hands thoroughly with soap and warm water.

02

Dry your hands completely before handling any testing supplies.

03

Ensure that you have all the necessary supplies ready, including a glucose meter, test strips, lancet device, and lancets.

04

Insert a new lancet into the lancet device and adjust the depth according to your skin type.

05

Select a clean and dry fingertip for blood sampling. Avoid using fingertips that are calloused, scarred, or injured.

06

Clean the selected area with an alcohol pad and let it dry completely.

07

Insert a test strip into the glucose meter following the manufacturer's instructions.

08

Use the lancet device to prick the side of your fingertip gently.

09

Squeeze the fingertip slightly to draw a small drop of blood.

10

Touch the test strip to the blood drop and wait for the glucose meter to display the result.

11

Record the glucose reading in a logbook or digital app for future reference.

12

Dispose of used lancets and test strips properly in a sharps container.

13

Wash your hands again to remove any residual blood.

Who needs capillary whole blood glucose?

01

Capillary whole blood glucose testing is commonly used by individuals with diabetes to monitor their blood sugar levels.

02

It is also used by healthcare professionals to diagnose and manage diabetes in patients.

03

Additionally, people with symptoms of hypoglycemia or hyperglycemia may use capillary whole blood glucose testing for immediate glucose level assessment.

04

Individuals who are at risk for developing diabetes or have a family history of diabetes may also use this testing method for early detection or prevention.

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What is capillary whole blood glucose?

Capillary whole blood glucose is a test that measures the amount of glucose in a sample of blood taken from a small pricked on the finger.

Who is required to file capillary whole blood glucose?

Individuals who need to monitor their blood glucose levels, such as diabetic patients, are required to file capillary whole blood glucose.

How to fill out capillary whole blood glucose?

To fill out capillary whole blood glucose, one must use a lancet to prick the finger, place a drop of blood on the glucose test strip, and then insert the strip into a glucose meter for reading.

What is the purpose of capillary whole blood glucose?

The purpose of capillary whole blood glucose is to monitor and manage blood glucose levels, especially in individuals with diabetes.

What information must be reported on capillary whole blood glucose?

The information reported on capillary whole blood glucose includes the date and time of the test, the glucose level reading, and any notes about the circumstances surrounding the test.

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