(163 days)
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No
The summary describes a standard blood glucose monitoring system with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No
The device is used for the "quantitative determination of glucose," which is a diagnostic function, not a therapeutic one. It monitors a condition rather than treating or preventing it.
Yes
Explanation: The intended use is "The quantitative determination of glucose in whole blood," which is a diagnostic purpose to measure a substance and aid in identifying a condition.
No
The device description explicitly lists hardware components (Meter, Test Strips, Control Solutions), indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "quantitative determination of glucose in whole blood." This clearly indicates that the device is used to test a sample taken from the body (whole blood) in vitro (outside the body) to provide diagnostic information (glucose levels).
- Device Description: The description lists "Blood Glucose Monitoring System (Meter, Test Strips, Control Solutions)". This is a classic example of an IVD system used for measuring analytes in biological samples.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissues, to detect diseases, conditions, or infections. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The quantitative determination of glucose in whole blood.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest feathers. The text is in a simple, sans-serif font and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 30 1998
Jeffrey P. Heaton Manager, Quality Assurance and Regulatory Affairs Chronimed, Inc. 6214 Bury Drive Eden Prairie, Minnesota 55346
K980573 Re : Sensorex Blood Glucose Monitoring System Regulatory Class: II Product Code: CGA Dated: May 22, 1998 May 26, 1998 Received:
Dear Mr. Heaton:
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 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 The general controls provisions of the Act 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 requlations 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 In addition, FDA may publish further announcements action. 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 requlations.
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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/dsmamain.html".
sincerely yours,
Steven Gutman
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
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510(k) Number (if known): Unknown
Blood Glucose Monitoring System Device Name: ( Meter, Test Strips, Control Solutions )
Indications for Use:
The quantitative determination of glucose in whole blood.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alan H. Linsak
(Division Sign-Off) Division of Clinical Laboratory Devices 167 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use ✓
(Optional Format 1-2-96)