(251 days)
Not Found
Not Found
No
The summary describes a standard blood glucose monitoring system and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details about training/test sets and performance metrics typically associated with AI/ML models.
No.
The device is used for monitoring blood glucose levels to aid in diabetes management, not for directly treating or curing a medical condition.
No
The text explicitly states: "The Gold AQ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes."
No
The device description explicitly states that the system is comprised of a blood glucose meter (hardware) and test strips (hardware/consumable), in addition to any potential software components.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states: "The Gold AQ Blood Glucose Monitoring System is for seff-testing outside the body (in vitro diagnostic use)."
N/A
Intended Use / 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 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: Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes
NBW
Device Description
The Gold AQ Blood Glucose Monitoring System is comprised of the Gold AQ blood glucose meter and the Gold AQ blood glucose test strip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
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.(b)
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.
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
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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)
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