(297 days)
The G4™ Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.
The G4™ Test Strips is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.
The G4™ Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.
The G4TM Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in capillary whole blood, which is used with the G4TM Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than providing a performance study report with acceptance criteria and results.
Here's what can be inferred from the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. For glucose meters, acceptance criteria typically involve accuracy standards (e.g., ISO 15197 or CLSI guidelines) such as percentage of results within a certain margin of a reference method (e.g., ±15% or ±0.83 mmol/L for glucose
§ 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.