(107 days)
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No
The summary describes a standard colorimetric glucose monitoring system and contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No.
Explanation: The device is a monitoring system and an in vitro diagnostic test kit used to measure blood glucose levels, not directly treat a medical condition.
Yes
Explanation: The device is used for "quantitative, colorimetric determination of glucose in whole blood specimens" and is intended for "people with diabetes to monitor their blood glucose levels." This process of determining a specific physiological parameter (glucose levels) to monitor a health condition (diabetes) falls under the definition of a diagnostic device, as it provides information used to identify or monitor a disease state.
No
The device description explicitly states "GO Glucose Monitoring System" and the intended use describes a "quantitative, colorimetric determination of glucose in whole blood specimens," which strongly implies the use of hardware components (like a meter and test strips) for the measurement. The summary does not provide any information suggesting it is solely software.
Yes, based on the provided information, the GO Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it's for the "quantitative, colorimetric determination of glucose in whole blood specimens." This involves testing a biological sample (whole blood) outside of the body to diagnose or monitor a medical condition (diabetes).
- "In vitro test kit": The description directly labels it as an "in vitro test kit," which is a key characteristic of IVDs.
- Monitoring blood glucose levels: The purpose is to monitor blood glucose levels, which is a common application for IVD devices used in managing diabetes.
Therefore, the intended use and the description clearly indicate that this device falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The GO Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose in whole blood specimens. The GO Glucose Monitoring System is intended for use by people with diabetes to monitor their blood glucose levels in a home use setting. This in vitro test kit is indicated for home use (over the counter).
Product codes
CGA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
people with diabetes / home use setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized design of what appears to be an eagle or bird-like figure, composed of three curved lines above three wavy lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 8 1999
Ms. Neda Rashti Director of Clinicals and Regulatory Affairs LXN Corporation 6325 Lusk Boulevard San Diego, California 92121
- Re: K991754
Trade Name: GO Glucose Monitoring System Regulatory Class: II Product Code: CGA Dated: August 2, 1999 Received: August 4, 1999
Dear Ms. Rashti:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 1
INTENDED USE STATEMENT
K991754 510(k) Number:
Device Name: GO Glucose Monitoring System
The GO Glucose Monitoring System is intended for the Intended Use: quantitative, colorimetric determination of glucose in whole blood specimens.
- The GO Glucose Monitoring System is intended for use by people Indication for Use: with diabetes to monitor their blood glucose levels in a home use setting. This in vitro test kit is indicated for home use (over the counter).
Scam Cogn
n-Off)
vision of Clinical Laboratory Devices
K 991754
ROKE Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of the CDRH, Office of the Device Evaluation
Prescription Use ﺮﺍﻧﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ
(Per 21 CFR 801.109)