(30 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
The device is an in vitro diagnostic (IVD) system used to measure glucose levels as an aid to monitor the effectiveness of diabetes control, not to provide therapy.
Yes
The device is described as an "In Vitro diagnostic use" system, intended for the quantitative measurement of glucose to "aid to monitor the effectiveness of diabetes control." This clearly indicates its purpose is diagnostic, specifically for monitoring a medical condition.
No
The description clearly outlines a "Test System" including a "Meter" and "Test Strips," which are physical hardware components used for in vitro diagnostic testing.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
The text explicitly states in multiple places:
- "Testing is done outside the body (In Vitro diagnostic use)."
- "Testing is done outside the body (In Vitro diagnostic use)."
- "Testing is done outside the body (In Vitro diagnostic use)."
This repeated phrasing, along with the description of measuring glucose in blood samples outside the body, clearly indicates that the EasyPlus mini MasterDriver SMBG Test System, including the meter and test strips, is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EasyPlus mini MasterDriver SMBG 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 MasterDriver Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Meter. Testing is done outside the body (In Vitro diagnostic use). They are 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 MasterDriver 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 MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are 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.
For use with the EasyPlus mini MasterDriver meter and EasyPlus mini MasterDriver 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
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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
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
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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).
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "HUMAN SERVICES - USA - DEPARTMENT" is written around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
EPS Bio Technology Corp. c/o Y. C. Lei General Manager 2F, No. 49-2, Lane 2 Guang Fu Rd., Sec. 2 Hsinchu City, (Taiwan) China 30071
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
OCT 2 1 2009
K092887 Re:
Trade Name: EasyPlus Mini MasterDriver SMBG System Regulation Number: 21 CFR $862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA Dated: September 18, 2009 Received: September 21, 2009
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 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
CA
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 Form
K092887 510(k) Number (if known):
EasyPlus mini MasterDriver SMBG system Device Name:
Indications for Use:
EasyPlus mini MasterDriver SMBG Test System
The EasyPlus mini MasterDriver SMBG 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.
EasyPlus mini MasterDriver Meter
The EasyPlus mini MasterDriver Meter is intended for the quantitative measurement of glucose in fresh capillary The Easy 160 min habert in on the fingertips or forearm. EasyPlus mini MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Meter. Testing is done outside the body (In Vitro diagnostic use). rnust of dood with the Each nover the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EasyPlus mini MasterDriver Blood Glucose Test Strips
The EasyPlus mini MasterDriver Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingerips or forearm. EasyPlus mini MasterDriver Blood in fresh oppliary while blood sen with the EasyPlus mini MasterDriver Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are 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.
EasyPlus mini MasterDriver Glucose Control Solutions
For use with the EasyPlus mini MasterDriver meter and EasyPlus mini MasterDriver Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
| Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR |
|---|---|
| ----------------------------------------------- | -------- |
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)
y
Division Siart-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092887