(216 days)
Not Found
No
The summary describes a standard electrochemical biosensor for glucose measurement and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating or preventing a disease.
No.
Explanation: The "Intended Use / Indications for Use" explicitly states that "The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus". It is instead an aid to monitor the effectiveness of diabetes control.
No
The device description explicitly mentions an "electrochemical biosensor technology" and "test strip," which are hardware components essential for the device's function. The 510(k) summary describes a physical system for measuring blood glucose, not a software-only application.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (in vitro diagnostic use)."
N/A
Intended Use / Indications for Use
The eBcarryon Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Product codes
NBW, CGA
Device Description
Based on an electrochemical biosensor technology and the principle of capillary action, eBcarryon Blood Glucose Monitoring System only needs a small amount of blood . Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood from the finger
Indicated Patient Age Range
The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates.
Intended User / Care Setting
It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
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)
Pre clinical and clinical data are employed upon submission of this 510(k) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System ; Guidance for Industry and FDA Document provided by CDRH/FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
5091765
Image /page/0/Picture/1 description: The image shows a small, pixelated black and white graphic. The graphic appears to be a stylized representation of a person or figure, possibly in a dynamic pose. Due to the low resolution and pixelation, specific details are difficult to discern, but the general shape suggests a human-like form with some artistic or abstract elements.
ISGENEER INC. -2, No.83, Sec.2, Gongdao 561 Rd., Hsinchu City 300, Taiwan Fax: 886-5160161 Tel: 886-3-5160111
Section III. Summary
JAN 1 9 2010
This Summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of (Per 21 CFR 807.92)
2.1 General Information Establishment
- Manufacturer: VISGENEER, INC.
- Registration Number : 3005644014 .
- 3F .- 2, No.83, Sec.2, Gongdao 5th Rd., Hsinchu City 300, . Address :
- Taiwan
- 886-3-5160111 Ext.3101 Phone :
- 0 Fax : 886-3-5160161
- Contact Person: Evonne Chen 0
- April 13t , 2009 Date Prepared :
2.2 Name of Device
| Trade Name: | eBcarryon Blood Glucose Monitoring System |
|---|---|
| Common Name: | Blood Glucose Monitoring System |
| Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, |
| OVER THE COUNTER, Class II, |
2.3 Predicate Device :
Claim of Substantial Equivalence (SE) is eBsensor Blood Glucose Monitoring System, eB-G. (K062555)
2.4 Description of Device :
Based on an electrochemical biosensor technology and the principle of capillary action, eBcarryon Blood Glucose Monitoring System only needs a small amount of blood . Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.
1
3F .- 2, No.83, Sec.2, Gongdao 5th Rd., Hsinchu City 300, Taiwan Fax: 886-5160161 Tel: 886-3-5160111
2.5 Intended Use:
The eBcarryon Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
2.6 Synopsis of Test Methods and Results:
Pre clinical and clinical data are employed upon submission of this 510(k) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System ; Guidance for Industry and FDA Document provided by CDRH/FDA.
- 2.7 Substantial Equivalence (SE):
A claim of substantial equivalence is made to Visgeneer INC. - eBsensor Blood Glucose Monitoring System, eB-G (K062555). Both of them have the same working principle and technologies. The differences are electric voltage, Meter Dimension of meter, Memory Storage, and weight. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Visgeneer, Inc. c/o Ms. Evonne Chen Supervisor of Control Quality Dept. 3F-2, No.83, Sec.2, Gongdao 5th Road. Hsinchu City Taiwan 30070
JAN 1 9 2010
Re: K091765
Trade name: eBcarryon Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: December 22, 2009 Received: December 22, 2009
Dear Ms. Chen:
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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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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
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
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Image /page/4/Picture/0 description: The image is a black and white graphic that appears to be a low-resolution scan or photograph of an object or scene. The details are not clear due to the image quality, but it seems to depict a textured or patterned surface with some darker areas that could be shadows or distinct features. The overall impression is that of a rough or uneven surface, possibly a close-up of a natural material or an abstract design.
VISGENEER INC. 3F -2, No.83, Sec.2, Gongdao 5th Rd., Hsinchu City 300, Taiwan Tel: 886-3-5160111 - Fax: 886-5160161
Indications for Use
510 (K) Number (If Known): KO9 17 65
Device Name: __eBcarryon Blood Glucose Monitoring System
Indications for Use:
The eBcarryon Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Prescription Use V and/or (21 CFR Part 801 Subpart D)
Over the Counter Use V (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD).
Carol Benam
! : on Sign-Off
See of In Vitro Diagnostic Device mation and Safety