# K161299: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Dec 23, 2016 after 228 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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: 6 generations back to K011233 (2001). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131750: Autosure HT Blood Glucose Monitoring System, Apex BioTechnology Corp. (2014) Summary page 5.

## Most influential descendants
- K222234: GlucoSure ADVANCE Link Blood Glucose Monitoring System (2022), 0 descendants of its own
- K182992: BGM014 Blood Glucose Monitoring System (2018), 0 descendants of its own

## Indications for use
The BGM014 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. Alterative 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 intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. 1t is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip. The Contrex Plus 5 glucose control solution is used with the BGM014 Meter and BGMO014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly. The BGMO014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in venous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. 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 intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGMO014 Pro Blood Glucose Monitoring System is comprised of the BGMO014 Pro Blood Glucose Meter and BGMO014 Pro Blood Glucose Test Strip. The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Meter and BGMO014 Pro Test Strip, Lo verify that the meter and test strip are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K161299
Methodology: https://510kreport.com/methodology