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The AP-1000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh) for self testing by persons with diabetes. The AP-1000 Blood Glucose Monitoring Systems is intended to be used by a single person and should not be shared. The AP-1000 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1000multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the alternative sites (palm, forearm, upper arm, calf, and thigh). The AP-1000multi Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing device. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1000 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1000 test strips and MAJOR control solution with the AP-1000 Blood Glucose Monitoring System.

The AP-1000multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1000multi test strips and MAJOR control solution with the AP-1000multi Blood Glucose Monitoring System.

The provided document describes the AP-1000 and AP-1000multi Blood Glucose Monitoring Systems. While it mentions "Performance Studies" that demonstrated the system's suitability for its intended use, it does not provide detailed acceptance criteria or the specific results of these studies.

The document primarily focuses on:

• Submitting entity and device identification.
• Device description (meter, test strip, control solutions).
• Intended use (quantitative measurement of glucose in capillary whole blood for self-testing by persons with diabetes and multi-patient use in professional healthcare settings).
• Comparison to a predicate device (K090389), stating "There are no any changes between the two devices" other than the new added AST function of K100437 device that is based K090389 device to re-test (this statement seems contradictory, as K100437 IS the new device with AST, and the predicate is K090389 which has no AST).
• A general conclusion that the system "demonstrates satisfactory performance."

Therefore, I cannot provide the requested information regarding specific acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert details, as these are not present in the provided text.

The document is a 510(k) summary, which often provides general statements about performance but refers to more detailed studies (which are usually proprietary and not included in the public summary) for the actual data.

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