# K170264: Gold AQ Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Changsha Sinocare, Inc.
- Decided: Oct 5, 2017 after 251 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Gold AQ Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. It is intended to be used by people with diabetes at home as an aid in monitoring the effectiveness of their diabetes control programs. The Gold AQ Blood Glucose Monitoring System is comprised of the Gold AQ blood glucose meter and the Gold AQ blood glucose test strip. The Gold AQ Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use). The Gold AQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Gold AQ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.

Source page: https://510kreport.com/device/K170264
Methodology: https://510kreport.com/methodology