# K103396: Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Sep 27, 2011 after 312 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K024194 (2003). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color), I-Sens, Inc. (2009) Summary page 2.

## Most influential descendants
- K121654: Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control Solution (2012), 0 descendants of its own

## Indications for use
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 altemate site testing should be used only during steady-state blood 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.

Source page: https://510kreport.com/device/K103396
Methodology: https://510kreport.com/methodology