(51 days)
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No
The provided text describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No.
This device is an in vitro diagnostic device used for monitoring blood glucose levels, not for treating a condition.
Yes
The device quantitatively measures glucose in blood samples to monitor the effectiveness of diabetes control, which is a diagnostic purpose.
No
The device description explicitly mentions a "Meter" and "Test Strips," which are hardware components necessary for the intended use of measuring glucose in blood samples. This indicates it is a hardware-based medical device system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This phrase is repeated for the overall system, the meter, and the test strips, clearly indicating that the device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The EasyPlus mini EasyMax Self Monitoring Blood Glucose Test System The EasyPlus mini EasyMax 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.
The EasyPlus mini EasyMax Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Meter. 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.
The EasyPlus mini EasyMax Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter IOTCI) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
For use with the EasyPlus mini EasyMax meter and EasyPlus mini EasyMax Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Product codes
NBW, CGA, JJY
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
Fingertips or forearm
Indicated Patient Age Range
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Intended User / Care Setting
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
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
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.
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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - (U.S.)" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
SEP 1 7 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
EPS Bio Technology Corp. c/o Y.C. Lei General Manager 2F, No. 49-2, Lane 2, Sec. 2 Guang Fu Road Hsinchu City China (Taiwan) 30071
Re: K082121
Trade Name: EasyPlus Mini Easy Max Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJY Dated: September 09, 2008 Received: September 12, 2008
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Jean M. Cooper, M.S., D.v.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology 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): K082121
Device Name: EasyPlus mini EasyMax Self-Monitoring Blood Glucose System
Indications For Use:
The EasyPlus mini EasyMax Self Monitoring Blood Glucose Test System The EasyPlus mini EasyMax 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.
The EasyPlus mini EasyMax Meter
The EasyPlus mini EasyMax Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Meter. 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.
The EasyPlus mini EasyMax Blood Glucose Test Strips
The EasyPlus mini EasyMax Blood Glucose Test Strips , are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini EasyMax Blood Glucose Test Strips must be used with the EasyPlus mini EasyMax Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter IOTCI) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The EasyPlus mini EasyMax Glucose Normal/High Control Solution
For use with the EasyPlus mini EasyMax meter and EasyPlus mini EasyMax Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
V Prescription Use
Over-The-Counter Use _ AND/OR
V
(Part 21 CFR 801 Subpart D)
(21 CFR 807 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) IVISIOn Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Sefety
KO82121