(306 days)
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No
The provided text describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No.
The device is an In Vitro diagnostic device intended for monitoring blood glucose levels, not for therapeutic intervention.
Yes.
The device is explicitly stated to be for "In Vitro diagnostic use" for the quantitative measurement of glucose, and is intended as "an aid to monitor the effectiveness of diabetes control," which are all diagnostic functions.
No
The device description explicitly states the system consists of a "Meter" and "Test Strips," which are hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Testing is done outside the body (In Vitro diagnostic use)."
This statement clearly identifies the device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EasyMax T1 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood qlucose conditions.
The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.
For use with the EasyMax T1 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EasyMax T1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.
For use with the EasyMax T1 Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW
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, forearm
Indicated Patient Age Range
Not to be used on neonates.
Intended User / Care Setting
Professional healthcare setting (EasyMax T1 Pro), home (over the counter [OTC]) by a single patient (EasyMax T1)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling birds in flight, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Image /page/0/Picture/4 description: The image shows a date, "JUN 21 2011". The month is JUN, the day is 21, and the year is 2011. The text is in bold font.
EPS BIO Technology Corp. c/o Y. C. Lei General Manager No. 8 R & D Road III -Hsinchu Science Park Hsinchu City, China (Taiwan) 30077
Re: K102345 Trade Name: EasyMax TI Self Monitoring Blood Glucose System, EasyMax TI Pro Self Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: CGA, NBW Dated: May 20, 2011 Received: May 23, 2011
Dear Y. C. Lei:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, 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): K102345
Device Name: EasyMax T1 Pro Self Monitoring Blood Glucose System
Indications for Use:
The EasyMax T1 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood qlucose conditions.
The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.
EasyMax T1 Glucose Control Solutions
For use with the EasyMax T1 Pro Self Monitoring Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
V Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-C
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)