# K220421: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Nov 4, 2022 after 263 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: 8 generations back to K011233 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202885: GlucoSure HT Plus Blood Glucose Monitoring System, Apex BioTechnology Corp. (2021) Summary page 5.

## Indications for use
The BGM039 Blood Glucose Monitoring System is comprised of the BGM039 Blood Glucose Meter and the BGM039 Blood Glucose Test Strips. The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood sanlples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control 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 BGM039 Link Blood Glucose Monitoring System is comprised of the BGM039 Link Blood Glucose Meter and the BGM039 Blood Glucose Test Strips. The BGM039 Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingeltips, forearm, or palm. Altemative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control 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.

Source page: https://510kreport.com/device/K220421
Methodology: https://510kreport.com/methodology