# K090712: Eocene System

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Oct 2, 2009 after 198 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 K942455 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051285: Glucolab Blood Glucose Monitoring System, Infopia Co, Ltd. (2005) Summary page 1.

## Indications for use
The GLUCOLAB™ Diabetes Monitoring System and EOCENE™ System is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites. The GLUCOLAB™ System and EOCENE™ System is not to be used for diagnosis, screening of diabetes or for neonatal use. The GLUCOLAB™ System and EOCENE™ System are for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh. GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly

Source page: https://510kreport.com/device/K090712
Methodology: https://510kreport.com/methodology