(88 days)
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No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components in its description, intended use, or performance summaries.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a disease or condition. It aids in monitoring the effectiveness of diabetes control but does not provide therapy itself.
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's for monitoring, not diagnosis.
No
The device description explicitly states the system consists of a meter and test strips, which are hardware components.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the EMV3 Pro and EMV3 systems explicitly states: "Testing is done outside the body (In Vitro diagnostic use)."
- Nature of the Test: The device measures glucose in fresh capillary whole blood, which is a biological sample taken from the body and tested in vitro (outside the living organism).
Therefore, the device clearly falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in 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 EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip.
The EMV3 Glucose Control Solution
For use with the EMV3 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EMV3 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip 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 EMV3 meter and the EMV3 test strips. The EMV3 meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm.
The EMV3 Glucose Control Solution
For use with EMV3 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Product codes
NBW, CGA
Device Description
The EMV3 Pro Self Monitoring Blood Glucose Test System consists of the EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip. The EMV3 Glucose Control Solution is for use with the EMV3 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EMV3 Self Monitoring Blood Glucose Test System consists of the EMV3 meter and the EMV3 test strips. The EMV3 meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm. The EMV3 Glucose Control Solution is for use with EMV3 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
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, Forearm
Indicated Patient Age Range
Not to be used on neonates.
Intended User / Care Setting
EMV3 Pro: multiple-patient use in professional healthcare settings.
EMV3: use at home (over the counter [OTC]) by a single patient 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
8 1 8 2017
EPS Bio Technology Corp. c/o Y. C. Lei No.8 R&D Rd III Hsinchu Science Park Hsinchu City, Hsinchu (Taiwan) China 30077
Re: K111728
Trade Name: EMV3 Self Monitoring Blood Glucose System EMV3 Pro Self Monitoring Blood Glucose System
Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW : CGA Dated: July 22, 2011 Received: August 19, 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 CIFR 803): and good manufacturing practice requirements as set forth in the quality svstems (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 contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please con regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the revoring 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 (1 01 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/des/11/11/1
Sincerely yours,
j
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form
510(k) Number (if known): K111728
Device Name: EMV3 Pro Self Monitoring Blood Glucose system
Indications for Use:
The EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in 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 EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip.
The EMV3 Glucose Control Solution
For use with the EMV3 Pro 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 V (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) K111728
Page 1 of 1
3
Indications for Use Form
510(k) Number (if known): K111728
Device Name: EMV3 Self Monitoring Blood Glucose system
Indications for Use:
The EMV3 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip 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 EMV3 meter and the EMV3 test strips. The EMV3 meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm.
The EMV3 Glucose Control Solution
For use with EMV3 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use V (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)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k-111728
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