# K130535: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application

- Pathway: 510(k) (Special)
- Applicant: Agamatrix, Inc.
- Decided: Apr 17, 2013 after 47 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: 5 generations back to K952279 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103544: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D, Agamatrix, Inc. (2011) Summary page 1.

## Most influential descendants
- K132148: S Health (2013), 0 descendants of its own

## Indications for use
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

Source page: https://510kreport.com/device/K130535
Methodology: https://510kreport.com/methodology