# K091157: Gluco Lab Auto Coding, Model Igm-0022

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Nov 17, 2009 after 210 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.
2 later devices descend from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- 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

## Indications for use
The GLUCOLAB Auto-coding 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 Auto-coding TM System provides plasma equivalent results. The GLUCOLAB Auto-coding TM System is not intended to be used with neonatal blood samples. The GLUCOLAB Auto-coding TM 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 Auto-coding TM control is used with GLUCOLAB Auto-coding TM 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/K091157
Methodology: https://510kreport.com/methodology