(153 days)
The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates.
The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions. The StatStrip Xpress Glucose Control Solutions are intended for use with the StatStrip Xpress Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results. There are 3 levels of controls (Levels 1, 2, and 3).
The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use).
The StatStrip Xpress Blood Glucose Monitoring System consists of a hand held StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), Instructions for Use Manual, and Quick Reference Guide.
The StatStrip Xpress Blood Glucose Monitoring System is identical in fit, form, and function to the StatStrip Xpress Glucose Hospital Meter System which was previously cleared in K150461. The Blood Glucose Monitor, Test Strip, and Control Solutions for both the StatStrip Xpress Blood Glucose Monitoring System (subject device) and StatStrip Xpress Glucose Hospital Meter System (reference device) are identical. The only difference between them is the intended use and labeling. The StatStrip Xpress Glucose Hospital Meter System was cleared in K150461 for use with critical care patients. This submission is to expand the intended use of Nova's StatStrip Xpress Glucose Meter System to include Over-the-Counter (OTC) use for single-patient home use.
The predicate device Nova Max Blood Glucose Monitoring System (K070255) was intended for OTC/home use.
As demonstrated in Table 2-1 below, the StatStrip Xpress Blood Glucose Monitoring System has the same intended use as the Nova Max Blood Glucose Monitor System. In addition, they are the same in the following characteristics:
- The Glucose Methodology: Glucose Oxidase Biosensor
- Test results: mg/dL, plasma equivalent values
- Sampling types : capillary whole blood obtained from the fingertip
- The size and weight
- The power source
- The monitor data storage
The major difference between the subject device and the predicate device is in their test strips. The Nova Max Blood Glucose Test Strips have two measurement wells; while the StatStrip Xpress Glucose Test Strips have four measurement wells. Both test strips utilize a Reference well and a Glucose measurement well. The two additional wells designed into the StatStrip Xpress Glucose Test Strips measure and correct for Electrochemical Interferences and Hematocrit. The improved design of the StatStrip Xpress Glucose Test Strip provides increased glucose measurement accuracy even under variable electrochemical interferences and hematocrit extremes. Therefore, the test range and acceptable Hematocrit range are different between the two systems as stated in the Table 2-1.
The StatStrip Glucose Test Strip reacts with the glucose in the test sample. The reaction produces an electrical current which is proportional to the amount of glucose in the sample, and the electrical current is detected by the monitor and displayed to the user as a glucose value.
Three levels of control solutions (Level 1, Level 3) are available for use with the StatStrip Xpress Blood Glucose Monitoring System and these were previously cleared in K150461.
The Nova Biomedical Corporation's StatStrip Xpress Blood Glucose Monitoring System underwent a clinical study to demonstrate its accuracy and usability for over-the-counter (OTC) home use.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard | Glucose Concentration Range | Acceptance Criterion | Reported Device Performance (%) | Meets Criteria |
|---|---|---|---|---|
| ISO 15197:2003 |
§ 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.