Gold AQ Blood Glucose Monitoring System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K170264

Identifiers

510(k) Number: K170264 FDA 510(k)
FDA Product Code: NBW FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1345 FDA 510(k)
Regulation Number: 862.1345 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Gold AQ Blood Glucose Monitoring System is a Blood Glucose Monitoring Device designed for the measurement of blood glucose levels in capillary whole blood. It provides quantitative results to aid in the management of diabetes and related metabolic conditions, offering real-time feedback for patient monitoring.

This system is supplied as a single-use, non-sterile device intended for home use. It includes test strips, a meter, and lancets, with no regulatory restrictions on MRI compatibility. The device is authorised under FDA 510K clearance (K170264) and complies with In Vitro Diagnostic Device (IVDD/IVDR) standards. Storage and handling follow manufacturer guidelines to ensure accuracy and reliability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

European Union Active

IVDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class II	Active
EUDAMED	European Union	IVDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K170264	Class II	Active

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Manufacturer

Manufacturer: Changsha Sinocare Inc.
FDA Applicant: Changsha Sinocare, Inc.

Sources (2)

FDA 510(k) K170264 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026