# K101204: Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Aug 31, 2011 after 488 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GlucoSure STAR meter and test strips: named in the summary without a submission number
- (no number) Contrex Plus glucose control solutions: named in the summary without a submission number

## Most influential descendants
- K120448: Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control (2012), 1 descendant of its own
- K143750: MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System (2015), 0 descendants of its own

## Indications for use
MEG-2 Blood Glucose Monitoring System: The MEG-2 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. 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. This system should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing can be used only during steady-state blood glucose conditions. MEG-2 Blood Glucose Test Strips: The MEG-2 Blood Glucose Test Strips are to be used with the MEG-2 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). They are intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. MEG-2 Glucose Control Solution: The MEG-2 Glucose Control Solutions are used with the MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly. MEG-2 Multi Blood Glucose Monitoring System: The MEG-2 Multi 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. Testing is done outside the body (In Vitro diagnostic use). It is indicated to be use for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing can be used only during steady-state blood glucose conditions. MEG-2 Multi Blood Glucose Test Strips: The MEG-2 Multi Blood Glucose Test Strips are to be used with the MEG-2 Multi Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is for use outside of the body (in vitro diagnostic use). It is indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing device.

Source page: https://510kreport.com/device/K101204
Methodology: https://510kreport.com/methodology