# K062799: Gluco Track Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Feb 6, 2007 after 140 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: 1 generation back to K011233 (2001). 1 ancestor in all.
18 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011233: Modification to Glucosure BGM System, Model 221100, Apex BioTechnology Corp. (2001) Summary page 1.

## Most influential descendants
- K073648: Glucosure Star Blood Glucose Monitoring System, Model AS90000E1 (2008), 13 descendants of its own
- 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

## Indications for use
The Gluco Track Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary, fingerstick whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for both lay use by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus.

Source page: https://510kreport.com/device/K062799
Methodology: https://510kreport.com/methodology