(93 days)
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No
The summary does not contain any keywords or descriptions related to AI or ML, and the device description is not available.
No
The device is indicated for monitoring blood glucose levels for persons with diabetes, which is a diagnostic/monitoring function, not a therapeutic intervention.
Yes
The device is a Blood Glucose Monitoring System intended to "measure glucose values" in blood, which is a diagnostic function for managing diabetes.
No
The description explicitly states the device is a "Blood Glucose Monitoring System" which implies hardware components (like a meter and test strips) are necessary to measure glucose values in blood. The lack of a "Device Description" section prevents a definitive confirmation, but the intended use strongly suggests a hardware component is integral to the system.
Based on the provided information, the EasyMate Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "measur[ing] glucose values in capillary, finger stick whole blood." This involves testing a biological sample (blood) outside of the body to provide information about a person's health status (glucose levels related to diabetes).
- Anatomical Site: The specified anatomical site is "capillary, finger stick whole blood," which confirms the use of a biological sample.
IVDs are defined as medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. The EasyMate system clearly fits this definition.
N/A
Intended Use / Indications for Use
The self-testing EasyMate Blood Glucose Monitoring System is indicated for use by healthcare professionals and persons with diabetes to measure glucose values in capillary, finger stick whole blood. Frequent monitoring of whole blood glucose is an adjunct to the care of persons with diabetes.
Product codes
NBW, JJY
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
healthcare professionals and persons with diabetes
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
MAR I 2006
Bioptik Technology, Inc. c/o Mr. Eric Luo. Ph.D. 6833 St. Lawrence Street Plano, TX 75024
K053312 Trade/Device Name: EasyMate Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JJY Dated: January 27, 2006 Received: January 30, 2006
Dear Dr. Luo:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_K053312
Device Name: EasyMate Blood Glucose Monitoring System
Indications For Use:
The self-testing EasyMate Blood Glucose Monitoring System is indicated for use by healthcare professionals and persons with diabetes to measure glucose values in capillary, finger stick whole blood. Frequent monitoring of whole blood glucose is an adjunct to the care of persons with diabetes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.A.C.
Division Bign-Off
Office of In Vitro Diagnostic Device Ev-luation and Safety
0533/2
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