The PRECICHEK Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, control solutions (Levels I and II; previously cleared under k032985), and a check strip. The meter will automatically turn on when a test strip is inserted. A small drop of blood contacts front end aperture which will cause the chamber to fill up on the front end of a test strip. When a beep sound is heard, the chamber is full and test reaction starts. When the test is done, the glucose result will appear on the meter’s LCD screen. Data will automatically be stored in memory.
Indication(s) for use:
The PRECICHEK Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The PRECICHEK Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The PRECICHEK Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
Precichek ACH Blood Glucose Test Strip
The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Blood Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
Precichek Glucose Control Solutions
The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is
Special conditions for use statement(s):
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Over the counter
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For testing on fingertip only
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Not intended for use on neonates
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Not for the diagnosis of or screening for diabetes mellitus
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Not to be used for patients who are dehydrated, hypotensive,
in shock, critically ill, or in a hyperosmolar state
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Should not be used on critically ill patients
How to use Precicheck Glucometer: