# K051651: G4, Model Igm-0004

- Pathway: 510(k) (Traditional)
- Applicant: U. S. Diagnostics, Inc.
- Decided: Apr 14, 2006 after 297 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: 2 generations back to K942455 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.

## Indications for use
The G4TM Meter device 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. G4TM 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 arm. The G4TM Test Strips 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. G4TM 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 arm. The G4TM Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.

Source page: https://510kreport.com/device/K051651
Methodology: https://510kreport.com/methodology