# K212140: GlucoSure Link Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Aug 25, 2022 after 413 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: 1 generation back to K102037 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102037: Autosure Voice II Blood Glucose Monitoring System and Test Strips, Apex BioTechnology Corp. (2010) Summary page 4.

## Indications for use
The GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips. The GlucoSure Link 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. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and not be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.

Source page: https://510kreport.com/device/K212140
Methodology: https://510kreport.com/methodology