(264 days)
The Veri-Q self-testing MGD-2001 Blood Glucose Monitoring System is intended for use in The quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q self-testing MGD-2001 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Veri-Q self-testing MGD-2001 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 Veri-Q sclf-testing MGD-2001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Veri-Q self-testing MGS-01 test strips are for use with the Veri-Q self-testing MGD-2001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm.
The Veri-O self-testing Glucose Control Solutions are for use with the Veri-Q self-testing MGD-2001 meter and the Veri-Q self-testing MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.
The Veri-Q plus MGD-2001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood drawn from fingertips, palm, or forearm. The Veri-Q plus MGD-2001 Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). The Veri-Q plus MGD-2001 Blood Glucose Monitoring System is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. The Veri-O plus MGD-2001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Veri-O plus MGS-01 test strips are for use with the Veri-Q plus MGD-2001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm.
The Veri-Q plus Glucose Control Solutions are for use with the Veri-Q plus MGD-20(01 meter and the Veri-Q plus MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.
The proposed Veri-Q self testing/ plus MGD-2001 Blood Glucose Monitoring System consists of a meter, test strips, control solutions (3 levels), a lancing device and sterile lancets. The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement. The Veri-Q testing/plus MGD-2001 meter is a no-code meter, so the responsibility of coding has been removed from the user. Each individual test strip contains technology that allows it to automatically calibrate and code the meter once it is inserted.
Here's an analysis of the acceptance criteria and supporting study for the Veri-Q self-testing/plus MGD-2001 Blood Glucose Monitoring System, based on the provided 510(k) summary:
The 510(k) summary states that "The testing for the Veri-Q self-testing/plus MGD-2001 Blood Glucose Monitoring System was performed in accordance with ISO 15197:2003." This standard specifies requirements for blood-glucose monitoring systems for self-testing and includes acceptance criteria for analytical performance. However, the exact acceptance criteria and reported device performance values are not explicitly stated in the provided text. To fulfill the request comprehensively, one would typically need to refer directly to ISO 15197:2003 and the full study report submitted with the 510(k). Since that detailed information is not available in the provided text, I will describe the kind of acceptance criteria typically found in ISO 15197:2003 and note the absence of specific reported performance.
A. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Typical ISO 15197:2003) | Reported Device Performance (from provided text) |
|---|---|
| **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.