# K143750: MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: May 7, 2015 after 127 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 K101204 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120448: Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control, Apex BioTechnology Corp. (2012) Summary page 5.

## Indications for use
The MEG-2B Blood Glucose Monitoring System, includes MEG-2B Blood Glucose Meter and MEG-2B Blood Glucose Test Strip, is intended for the quantitative measurement of glucosc in [resh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucose is not changing rapidly). It is indicated for use by lay people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for self-testing outside the body (in vitro diagnostic use) and should not be shared. It is not indicated for the diagnosis or screening of diabeles or for nconatal usc. The MEG-2B Pro Blood Glucose Monitoring System includes MEG-2B Pro Blood Glucose Meter and MEG-2B Pro Blood Glucosc Test Strip, is intended for the quantitative measurcment of glucosc in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternate site testing should be done only during steady -state times (when glucosc is not changing rapidly). This sysicm is indicated for multiple-paticnt usc in profcssional healthcare scitings as an aid to monitor the effectiveness of diabetes control programs. It is only used with single-use, auto-disabling lancing device. It is intended for tesling outside the body (in vitro diagnostic usc). It is not indicated for the diagnosis or screcning of diabetes or for neonatal use.

Source page: https://510kreport.com/device/K143750
Methodology: https://510kreport.com/methodology