Gold AQ Blood Glucose Monitoring System

K170264 · Changsha Sinocare, Inc. · NBW · Oct 5, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170264
• Device Name: Gold AQ Blood Glucose Monitoring System
• Applicant: Changsha Sinocare, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of diabetes. It is not intended for use on neonates.

Device Story

System consists of hand-held, battery-powered meter and disposable electrochemical test strips. User applies 0.8 μL capillary whole blood from fingertip to test strip via capillary action. Device uses FAD-glucose dehydrogenase (GDH-FAD) chemistry to generate electrical current proportional to glucose concentration. Meter measures current, calculates glucose level, and displays result in mg/dL. Intended for single-patient home use; not for clinical settings. Provides quantitative data to assist patients in managing diabetes control programs. Includes automatic control solution detection and error messaging for insufficient sample or used strips. Meter stores 500 blood glucose and 100 control solution results.

Clinical Evidence

User performance study with 105 lay users comparing self-tested capillary blood glucose results against YSI 2300 laboratory reference method. For glucose <75 mg/dL, 100% (11/11) of results were within ±10 mg/dL. For glucose ≥75 mg/dL, 98.9% (93/94) of results were within ±20% of reference values. Human factors/usability study confirmed users could follow labeling instructions.

Technological Characteristics

In vitro diagnostic glucose test system; consists of a meter and test strips for capillary whole blood analysis. Product code NBW; Class II.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the fingertip for people with diabetes to monitor control programs. For single-patient, home use. Contraindicated for neonates, diabetes diagnosis, or screening.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 5, 2017

SINOCARE MEDITECH, INC. C/O JACQUELINE DAVIS TRIVIDIA HEALTH, INC. 2400 NW 55TH CT. FT. LAUDERDALE FL 33309

Re: K170264

Trade/Device Name: Gold AQ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: August 17, 2017 Received: August 18, 2017

Dear Jacqueline Davis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Kellie B. Kelm -S**

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K170264

Device Name Gold AQ Blood Glucose Monitoring System

## Indications for Use (Describe)

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 seff-testing outside the body (in vitro diagnostic use).

The Gold AO 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.

Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."