# K102816: Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Sep 15, 2011 after 352 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 K011233 (2001). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073648: Glucosure Star Blood Glucose Monitoring System, Model AS90000E1, Apex BioTechnology Corp. (2008) Summary page 1.
- K100747: Contrex Plus Low Control Solution, Apex BioTechnology Corp. (2010) Summary page 1.

## Most influential descendants
- K113208: Gal-1A Blood Glucose Monitoring System (2012), 9 descendants of its own
- K141036: BGM009 Blood Glucose Monitoring System (2015), 3 descendants of its own
- K131750: Autosure HT Blood Glucose Monitoring System (2014), 3 descendants of its own
- K170267: BGM009 Plus Blood Glucose Monitoring System (2017), 2 descendants of its own
- K161299: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System (2016), 2 descendants of its own

## Indications for use
The GAL-IC Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The GAL- IC Blood Glucose Test Strips are to be used with the GAL- IC Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Source page: https://510kreport.com/device/K102816
Methodology: https://510kreport.com/methodology