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The CareSens S Clear BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Clear BT Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The CareSens S Blood Glucose Test Strips are for use with the CareSens S Clear BT Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

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This is an FDA 510(k) clearance letter for a medical device (CareSens S Clear BT Blood Glucose Monitoring System), not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria, device performance, or study specifics like sample sizes, ground truth establishment, or expert qualifications.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. The "Indications for Use" section (page 2) describes what the device is intended for, but it does not present acceptance criteria or performance data for meeting those criteria.

To answer your questions, one would need to access the full 510(k) submission, which is typically not publicly available in its entirety in this format. The 510(k) submission would contain the detailed studies and data to demonstrate substantial equivalence, including performance data against specific acceptance criteria.

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