# K062892: Eukare

- Pathway: 510(k) (Traditional)
- Applicant: Eumed Biotechnology Co., Ltd.
- Decided: Jan 22, 2007 after 118 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002621 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040678: Eusure Blood Glucose Monitoring System, Eumed Biotechnology Co., Ltd. (2004) Summary page 1.

## Recalls of this device
- Aug 14, 2007 · Not classified · Z-0134-2008: Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths

## Indications for use
The EUKARE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. CAUTION. The measurement of glucose in whole blood can be taken from the finger only, and this is not for neonatal use. The EUKARE Blood Glucose Test Strips are intended to measure the glucose levels in whole blood with the EUKARE® / EUSURE® Blood Glucose Monitoring System. It is suitable for persons with diabetes to monitor their blood glucose levels at home by themselves. The system can also be used at clinical sites by health care professionals to test the blood glucose levels of patients. CAUTION: The EUKARE Blood Glucose Test Stripsfor use with EUKARE®/ EUSURE®Blood Glucose MonitoringSystem only. The EUKARE Blood Glucose Control Solution level I, level II, and level III are used as quality control material to verify the accuracy of the EUKARE® EUSURE® Blood Glucose Monitoring System. If you are not sure about the strip quality or the previous storage condition, you are recommended to perform a quality control check. The control test results should always fall within the designed range listed on the box in use. CAUTION: The EUKCARE Blood Glucose ControlSolution for use with EUKARE® /EUSURE® Blood Glucose MonitoringSystem only.

Source page: https://510kreport.com/device/K062892
Methodology: https://510kreport.com/methodology