(28 days)
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No
The description focuses on standard glucose measurement technology and does not mention any AI or ML components.
No
The device is a self-monitoring blood glucose system used for quantitative measurement of glucose, serving as an aid to monitor diabetes control. It does not actively treat or provide therapy.
No
The text explicitly states: "The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus." This indicates it is not a diagnostic device, but rather an aid for monitoring.
No
The device description explicitly states the system consists of a "meter" and "test strips," which are hardware components, not solely software.
Yes, both the EasyMax MU Self Monitoring Blood Glucose System and the EasyMax MU Pro Self Monitoring Blood Glucose System are IVDs (In Vitro Diagnostics).
The text explicitly states for both devices: "Testing is done outside the body (In Vitro diagnostic use)." This is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EasyMax MU Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, 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 MU meter and the EasyMax MU test strips. The EasyMax MU meter only is used with the EasyMax MU test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EasyMax MU Glucose Control Solution: For use with EasyMax MU Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EasyMax MU Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings 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.
The system consists of the EasyMax MU Pro meter and the EasyMax MU Pro test strips. The EasyMax MU Pro meter only is used with the EasyMax MU Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EasyMax MU Glucose Control Solution: For use with the EasyMax MU Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood qlucose test results.
Product codes
LFR, NBW, JJX
Device Description
The system consists of the EasyMax MU meter and the EasyMax MU test strips. The EasyMax MU meter only is used with the EasyMax MU test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The system consists of the EasyMax MU Pro meter and the EasyMax MU Pro test strips. The EasyMax MU Pro meter only is used with the EasyMax MU Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
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
fingertip, palm, forearm (for EasyMax MU); venous, fingertip (for EasyMax MU Pro)
Indicated Patient Age Range
Not to be used on neonates.
Intended User / Care Setting
EasyMax MU: at home (over the counter [OTC]) by a single patient with diabetes.
EasyMax MU Pro: multiple-patient use in professional healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
EPS Bio Technology Corp c/o Cynthia Hung No.8 R & D Rd III Hsinchu Science Park Hsinchu City, China (Taiwan) 30077
MAY 1 8 2012
Re: K121207
Trade Name: EasyMax MU Self Monitoring Blood Glucose System, EasyMax MU Pro Self Monitoring Blood Glucose System
Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: LFR, NBW, JJX Dated: April 16, 2012 Received: April 20, 2012
Dear Ms Hung:
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 Part 801), please If you desire specific advice so: your stic Device Evaluation and Safety at (301) 796-5450. Also, common the office of in 1 reso Diage Misbranding by reference to premarket notification" (21 productions increations regarding postmarket surveillance, please contact CDRH is Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Surveinance and Drolling of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address (000) 030 2611 00 v/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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):
Device Name: EasyMax MU Self Monitoring Blood Glucose system
Indications for Use:
The EasyMax MU Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, 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 MU meter and the EasyMax MU test strips. The EasyMax MU meter only is used with the EasyMax MU test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EasyMax MU Glucose Control Solution
For use with EasyMax MU Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K12120
Page 1 of 2
3
Indications for Use
510(k) Number (if known):
Device Name: EasyMax MU Pro Self Monitoring Blood Glucose system
Indications for Use:
The EasyMax MU Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings 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.
The system consists of the EasyMax MU Pro meter and the EasyMax MU Pro test strips. The EasyMax MU Pro meter only is used with the EasyMax MU Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EasyMax MU Glucose Control Solution
For use with the EasyMax MU Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood qlucose test results.
Prescription Use X (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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121207
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