Search Results

The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The BGM039 Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

BGM039 brand of Blood Glucose Monitoring System is designed to have two variation models, BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System. BGM039 Blood Glucose Monitoring System is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, BGM039 Link Blood Glucose Monitoring System is implemented with all of the changes stated in the submission. The two meters use the same BGM039 Test Strip and Contrex Plus 4 Control Solution. This Premarket Notification (510(k)) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device, GlucoSure HT Plus Blood Glucose Monitoring System, K202885.

BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System consists of the blood glucose meter and single use test strips. It is used for testing of blood glucose by self-testers at home.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive summary. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical testing section and the overall context of a blood glucose monitoring system, we can infer some general acceptance criteria for such devices, especially concerning accuracy. The FDA's guidance for blood glucose monitoring systems generally requires specific accuracy levels.

Here's an attempt to answer your questions based on the available information and common practices for blood glucose monitoring systems, with explicit mention of where information is not provided in the text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., in terms of percentage agreement or mean absolute relative difference) nor does it provide a table of performance statistics for the accuracy test.

It mentions "accuracy test" in the non-clinical testing section, implying that such a test was conducted. For blood glucose meters, common acceptance criteria from standards like ISO 15197 (which is often referenced by the FDA) are:

Ask a specific question about this device