(28 days)
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 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 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.
The provided text from the 510(k) clearance letter and Indications for Use forms for the EasyMax MU and EasyMax MU Pro Self Monitoring Blood Glucose Systems does not contain the detailed information required to answer all parts of your request.
Specifically, the document focuses on regulatory clearance and intended use, but it does not include results from device performance studies, acceptance criteria, sample sizes for test sets, details on ground truth establishment, or information about AI assistance or human reader studies. It's common for these details to be in separate technical documentation submitted to the FDA, not typically summarized in the public-facing clearance letter.
Therefore, I can only address the parts of your request that can be inferred from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify performance metrics (e.g., accuracy, precision) or acceptance criteria for those metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention sample sizes for any test sets or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. The document does not describe how ground truth was established, nor does it mention any experts involved in such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. The document does not describe any adjudication methods.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The EasyMax MU and EasyMax MU Pro systems are Self Monitoring Blood Glucose Systems, meaning they are standalone devices for measuring glucose. They are not AI-assisted imaging devices or diagnostic tools that would involve "human readers" in the sense of interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, by nature of the device. While not described as an "algorithm" in a software sense, the blood glucose measurement system inherently operates as a standalone device without human interpretation of the measurement result itself. The device provides a quantitative glucose reading directly. The "performance" being referred to would be the accuracy and precision of the device's quantitative glucose measurement against a reference method. The document implicitly confirms this is a standalone device through its description as "quantitative measurement of glucose."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred: Reference laboratory method. For blood glucose monitoring systems, the "ground truth" or reference standard for comparison is typically a highly accurate laboratory-based glucose analyzer (e.g., hexokinase method). The document doesn't explicitly state this, but it's standard for this type of device.
8. The sample size for the training set
- Cannot be provided. The document does not mention any "training set" or its size. For a blood glucose meter, the "training" (calibration) is typically done during the manufacturing process and verified.
9. How the ground truth for the training set was established
- Cannot be provided. As above, no information on a training set or its ground truth establishment is present.
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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
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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
Page 2 of 2
§ 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.