# K051285: Glucolab Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Aug 2, 2005 after 77 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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: 2 generations back to K942455 (1995). 5 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 2.
- K984261: Surestep Blood Glucose Monitoring System, Lifescan, Inc. (1999) Summary page 2.
- K021513: Accu-Chek Advantage Module, Roche Diagnostics Corp. (2002) Summary page 2.

## Most influential descendants
- K091157: Gluco Lab Auto Coding, Model Igm-0022 (2009), 2 descendants of its own
- K113192: Healthpro Blood Glucose Monitoring System (2012), 1 descendant of its own
- K132862: Healthpro Professional Blood Glucose Monitoring System (2013), 0 descendants of its own
- K091168: Glucophone Blood Glucose Test System, Model Igm-0025 (2010), 0 descendants of its own
- K090712: Eocene System (2009), 0 descendants of its own

## Indications for use
The GLUCOLAB TM Diabetes Monitoring System is used for the quantitative measurement of glucose level in 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 TM System provides plasma-equivalent results. The GLUCOLABTM System is not intended to be used with neonatal blood samples. The GLUCOLABTM System is 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 GlucoLabTM Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do control solution tests routinely to make sure you are getting accurate results. Control Solutions are sold separately

Source page: https://510kreport.com/device/K051285
Methodology: https://510kreport.com/methodology