# K142689: GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Aug 6, 2015 after 318 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: 5 generations back to K011233 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113547: Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E Multi Blood Glucose Monitoring System Gal, Apex BioTechnology Corp. (2012) Summary page 5.

## Indications for use
The GAL-1F 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 blood glucose 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-1F Pro 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 to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring blood glucose levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Source page: https://510kreport.com/device/K142689
Methodology: https://510kreport.com/methodology