# K073648: Glucosure Star Blood Glucose Monitoring System, Model AS90000E1

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Apr 10, 2008 after 106 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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 K011233 (2001). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062799: Gluco Track Blood Glucose Monitoring System, Apex BioTechnology Corp. (2007) Summary page 1.

## Most influential descendants
- K102816: Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips (2011), 12 descendants of its own
- 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

## Indications for use
GlucoSure Star Blood Glucose Monitoring System: The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. GlucoSure Star Test Strips: The GlucoSure Star Blood Glucose Test Strips are to be used with the GlucoSure Star Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Source page: https://510kreport.com/device/K073648
Methodology: https://510kreport.com/methodology