(585 days)
The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-695 Single 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 AG-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a qlucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 MULT! Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.
The AG-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a alucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
This system should only be used with single-use, auto-disabling lancing devices.
The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The AG-696 Single 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 AG-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.
The AG-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.
The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 MULT! Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.
This system should only be used with single-use, auto-disabling lancing devices.
The four blood Glucose Monitoring system AG-695 Single, AG-695 MULTI, AG-696 Single and AG-696 MILTI are all based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing but the appearance is different from their predicate device. More over, all of the four systems have a voice function.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AG-695/AG-696 Blood Glucose Monitoring Systems:
The provided document is a 510(k) Summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of accuracy, sensitivity, and specificity in the way one might for a diagnostic imaging AI. For blood glucose monitoring systems (BGMS), the primary acceptance criteria revolve around the accuracy of glucose measurements compared to a laboratory reference method, as defined by standards like ISO 15197.
1. Table of Acceptance Criteria and Reported Device Performance
The document references compliance with ISO 15197 and FDA Draft Guidance Document "Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006." These standards set forth the acceptance criteria for accuracy. While the document mentions compliance, it does not explicitly present a table of acceptance criteria or detailed device performance statistics (e.g., mean absolute relative difference, percentage of results within specific error margins) in the provided text.
However, based on typical ISO 15197 (2003) guidelines (the likely version for a 2011 submission), common acceptance criteria for accuracy are:
| Acceptance Criteria (Typical ISO 15197:2003) | Reported Device Performance |
|---|---|
| **For glucose concentrations |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.