(263 days)
The ACCU-CHEK Performa Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from the fingertips. The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid in monitoring the effectiveness of glucose control. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use.
The ACCU-CHEK Performa test strips are for use with the ACCU-CHEK Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
The ACCU-CHEK Performa blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Performa test strips, the ACCU-CHEK Performa meter, the ACCU-CHEK Inform II Control Solutions (cleared under K121679), and the ACCU-CHEK Inform II Linearity Test Kit (cleared under K121679). This system is a multi-patient use blood glucose monitoring system intended to be used in a professional environment to quantitatively measure glucose in venous whole blood and fresh capillary whole blood samples drawn from the fingertips.
The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous or fresh capillary whole blood. The system is for in vitro diagnostic use in professional healthcare settings and should only be used with single-use, auto-disabling lancing devices. It is not for the diagnosis or screening of diabetes, nor for neonatal use.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as criteria, but inferred from data presentation as performance targets) | Reported Device Performance (ACCU-CHEK Performa System) |
|---|---|
| Method Comparison (vs. YSI Glucose Analyzer): | |
| 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.