# K120448: Meg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Apr 6, 2012 after 52 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K101204 (2011). 1 ancestor in all.
1 later device descends 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)
- K101204: Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control Solution, Apex BioTechnology Corp. (2011) Summary page 1.

## Most influential descendants
- K143750: MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System (2015), 0 descendants of its own

## Recalls of this device
- Sep 18, 2019 · Class II · Z-0513-2020: Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.

## Indications for use
The MEG-2B3 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. 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. The MEG-2B3 Blood Glucose Test Strips are to be used with the MEG-2B3 Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. 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. The MEG-2B3 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. 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. The MEG-2B3 Pro Blood Glucose Test Strips are td be used with the MEG-2B3 Pro Blood Glucose Meter; it measures glucose in capillar whole blood taken from a fingertip; palm, or forearm. 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. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a-known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Source page: https://510kreport.com/device/K120448
Methodology: https://510kreport.com/methodology