# K103544: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D

- Pathway: 510(k) (Traditional)
- Applicant: Agamatrix, Inc.
- Decided: Dec 7, 2011 after 370 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: 4 generations back to K952279 (1995). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071393: Jazz Blood Glucose Monitoring System, Agamatrix (2007) Summary page 1.
- K101597: Wavesense Diabetes Manager Model Version 1.3.4, Agamatrix (2010) Summary page 1.

## Most influential descendants
- K131230: Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application (2014), 4 descendants of its own
- K150817: Dario Blood Glucose Monitoring System (2015), 2 descendants of its own
- K152365: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (2016), 1 descendant of its own
- K130535: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application (2013), 1 descendant of its own
- K172723: Dario LC Blood Glucose Monitoring System (2018), 0 descendants of its own

## Indications for use
The iBGStar™ Blood Glucose Monitoring System is Intended for the quantitative measurement of blood glucose levels in 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 pauenl and should not be used for testing multiple patients. 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. BGStar™ Test Strips are for use with the iBGStar™ Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. Palm and forearm testing (Alternative Site Testing) should be done only during steady-state times (when glucose is not changing rapidly). BGStar Control Solutions are for use with the iBGStar™ Blood Glucose Meter and BGStar Test Strips to check that the meter and test strips are working together properly and that the test is performmg correctly. 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/K103544
Methodology: https://510kreport.com/methodology