(312 days)
The COOL Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The COOL Blood Glucose Meter is intended for use with the COOL Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis of or screening for diabetes.
The COOL Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: COOL Meter (Model GM505MA), COOL Test Strips, COOL Control Solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.
This 510(k) summary (K103396) describes the COOL Blood Glucose Monitoring System, which is substantially equivalent to the predicate CareSens N Blood Glucose Monitoring System (K083468). The modifications in the COOL system are limited to the meter's outer casing design and the test strip's electric connector pattern.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes two performance studies: Repeatability Test (PE-01) and Linearity Study (PE-03). The studies were conducted to verify the proper operation of the modified electric connector of the COOL test strip with the COOL meter.
Repeatability Test (PE-01):
| Interval | Mean Concentration (mg/dL) | Acceptance Criteria | Reported Performance | Met Acceptance Criteria? |
|---|---|---|---|---|
| 1 | 30 to 50 | SD = 100 | CV |
§ 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.