(92 days)
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No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is described as a "Blood Glucose System" intended for the "quantitative measurement of glucose" as an "aid to monitor the effectiveness of diabetes control." It performs a measurement (diagnostic function) and does not directly provide therapy or treatment.
Yes
The text explicitly states "Testing is done outside the body (In Vitro diagnostic use)" for both the EMV3.1 Pro and EMV3.1 Self Monitoring Blood Glucose Systems, indicating that they are diagnostic devices.
No
The device description explicitly states that the system consists of a "meter" and "test strips," which are hardware components. It does not describe a software-only solution.
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 EMV3.1 Pro and the EMV3.1 Self Monitoring systems explicitly states: "Testing is done outside the body (In Vitro diagnostic use)."
- Nature of the Test: The device measures glucose in blood samples, which is a biological specimen tested in vitro (outside the living organism) to provide information about a person's health status.
Therefore, the device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EMV3.1 Pro 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 Viro 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 includes the speaking function but is not intended to be operated by visually impaired users.
The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EMV3.1 Glucose Control Solution: For use with the EMV3.1 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EMV3.1 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 includes the speaking function but is not intended to be operated by visually impaired users. 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 EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EMV3.1 Glucose Control Solution: For use with EMV3.1 Blood Glucose Self Monitoring 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)
NBW, LFR, JJX
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
venous whole blood or fresh capillary whole blood from fingertip; fresh capillary whole blood from fingertip, palm, or forearm.
Indicated Patient Age Range
The system is not to be used on neonates.
Intended User / Care Setting
multiple-patient use in professional healthcare settings; 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): 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.
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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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2014
EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG NO.8 R&D RD III, HSINCHU SCIENCE PARK HSINCHU CITY, 30077 TAIWAN
Re: K133647
Trade/Device Name: EMV3.1 Self Monitoring Blood Glucose System EMV3.1 Pro Blood glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: January 29, 2014 Received: January 30, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices . Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K133647
Device Name EMV3.1 Pro blood Glucose system
Indications for Use (Describe)
The EMV3.1 Pro 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 Viro 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 includes the speaking function but is not intended to be operated by visually impaired users.
The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EMV3.1 Glucose Control Solution
For use with the EMV3.1 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133647
Device Name
EMV3.1 Self Monitoring Blood Glucose system
Indications for Use (Describe)
The EMV3.1 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 includes the speaking function but is not intended to be operated by visually impaired users. 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 EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EMV3.1 Glucose Control Solution
For use with EMV3.1 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."