(156 days)
Not Found
Not Found
No
The provided text describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No.
The device is for monitoring glucose levels, not for treating diabetes. It is an "aid to monitor the effectiveness of diabetes control," which is a diagnostic or monitoring function, not a therapeutic one.
No
The device is explicitly stated as "not intended for the diagnosis of or screening for diabetes." Instead, it is an "aid to monitor the effectiveness of diabetes control."
No
The device description explicitly mentions a "EasyMax V Meter" and "EasyMax V Blood Glucose Test Strips," which are hardware components necessary for the intended use of measuring glucose.
Yes, the text explicitly states that the EasyMax V Self Monitoring Blood Glucose Test System, the EasyMax V Meter, and the EasyMax V Blood Glucose Test Strips are intended for In Vitro diagnostic use.
The description of the intended use clearly defines that the testing is done "outside the body," which is a key characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EasyMax V Self Monitoring Blood Glucose Test 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 persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.
The EasyMax V Meter 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 persons with diabetes, or in clinical settings by heatthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.
The EasyMax V Blood Glucose Test Strips 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 persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.
For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips 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, CGA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips or forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals
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
Not Found
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): 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.
Not Found
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.
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).
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three curved lines representing its body and wings. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
EPS Bio Technology Corporation c/o Mr. Y.C. Lei General Manager 2F, No. 49-2, Lane 2, Sec. 2, Guang Fu Road Hsinchu City, China (Taiwan) 30071
FEB 2 L 2010
Re: K092894
Trade/Device Name: EasyMax V SMBG System Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: January 21, 2010 Received: January 25, 2010
Dear Mr. 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 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).
1
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 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 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
AC
Courtney C. 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
2
Indications for Use
510(k) Number (if known): K092894
Device Name: EasyMax V SMBG system
Indications for Use:
EasyMax V SMBG Test System
The EasyMax V Self Monitoring Blood Glucose Test 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 persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.
EasyMax V Meter
The EasyMax V Meter 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 persons with diabetes, or in clinical settings by heatthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.
EasyMax V Blood Glucose Test Strips
The EasyMax V Blood Glucose Test Strips 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 persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates.
EasyMax V Glucose Control Solutions
For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Prescription Use V (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)
.
Livesion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
v 092894 (; ' > '1 .. ' .. ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '