(88 days)
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Not Found
No
The summary describes a standard blood glucose monitoring system and contains no mention of AI, ML, or related technologies.
No
The device is an in vitro diagnostic (IVD) tool used for monitoring blood glucose levels, not for treating a condition.
Yes
The device is intended for the quantitative measurement of glucose to monitor the effectiveness of diabetes control, which is a diagnostic purpose.
No
The device is described as a "Self Monitoring Blood Glucose Test System" which measures glucose in blood samples. This strongly implies the use of hardware components (like a meter and test strips) to perform the measurement, making it a hardware-based in vitro diagnostic device, not a software-only device.
Yes, the provided text explicitly states that the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly says:
"Testing 1s done outside the body (In Vitro diagnostic use)"
N/A
Intended Use / Indications for Use
The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing 1s done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control
Product codes
NBW, 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
fingertips or forearm
Indicated Patient Age Range
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Intended User / Care Setting
at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
EPS B10 Technology Corp c/o Mr Y C Lei General Manager 2F, No 49-2, Lane 2, Guang Fu Rd , Sec 2 Hsinchu City, Tarwan, ROC
JAN 1 6 2009
Re K083099
Trade/Device Name EasyMax N Self-Monitoring Blood Glucose Meter Regulation Number 21 CFR 862 1345 Regulation Name Glucose test system Regulatory Class Class II Product Code NBW, CGA Dated December 19, 2008 Received December 22, 2008
Dear Mr Leı
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 regustration. Insting 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 Iogally marketed predicate device results in a classification for your device and thus, begine to repress 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 (301) 594-3084 Also, please note the regulation entitled, "Mısbranding 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 tolloffre and ber (800) 638-2041 or (301) 443-6597 or at 1ts Internet address http //www fda gov/cdrh/dsma/dsmamain html
Sincerely yours,
Cory C. Hill
Courtney C Harper, Ph D Acting Director DIVISIOn of Chemistry and Tox1cology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known) K083099
Device Name EasyMax N Self Monitoring Blood Glucose Test System
Indication For Use
The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing 1s done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control
Prescription Use V (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use V (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
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Division Sign-Off Office of In Vitro Diagnostic Device
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