(218 days)
Not Found
No
The description focuses on the electrochemical principle of glucose measurement and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) product used for monitoring blood glucose levels, not for treating a disease or condition. It aids in monitoring the effectiveness of diabetes management, but it does not provide therapy itself.
No
The device is explicitly stated as "not for the diagnosis or screening of diabetes". It is intended for monitoring effectiveness of diabetes management.
No
The device description explicitly states it is an "in vitro diagnostic device designed for measuring the concentration of glucose in whole blood" and mentions a "Monitor" and "Test Strips" which are hardware components. The principle of the test involves an electrochemical reaction measured by a "Meter".
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "EasyGluco® Plus System is for self testing outside the body (in vitro diagnostic use only)".
- Device Description: The "Device Description" section also states: "The EasyGluco® Plus Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood...".
- Test Principle: The description of the test principle clearly outlines a chemical reaction occurring on the test strip with a blood sample, which is a hallmark of in vitro diagnostics.
- Purpose: The device is intended to measure a substance (glucose) in a biological sample (blood) outside of the body to aid in monitoring a medical condition (diabetes). This aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by patients with diabetes. The EasyGluco® Plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared with any other person.
EasyGluco® Plus System is for self testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The EasyGluco® Plus Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The EasyGluco® Plus Blood Glucose Test Strips are for use with the EasyGluco® Plus Blood Glucose Monitor for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forcarm, calf or thigh.
Product codes
NBW, CGA
Device Description
The EasyGluco® Plus Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EasyGluco® Plus Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients with diabetes in the home / self testing outside the body (in vitro diagnostic use only) by people with diabetes at home
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)
Reference Device(s)
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.
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SEP 2 1 2011
:
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| Introduction: | According to the requirements of 21 CFR.807.92, the following information provides sufficient data to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitted By: | US Diagnostics, Inc. |
| 304 Park Avenue South | |
| Suite 218 | |
| New York, NY 10010 | |
| Contact Person: | Jonathan Johnson |
| Phone: 646-454-5401 | |
| Fax: 800-931-9137 | |
| Date Summary, Prepared: | September 8, 2011 |
| Device Name: | Propriety Name: EasyGluco® Plus Blood Glucose Monitoring System |
| Common Name: Blood Glucose Test System | |
| Classification Name: Class II, 862.1345 Blood Glucose Monitoring System | |
| Predicate Device: | We claim substantial equivalence to the G5 Infinity Blood Glucose Monitoring System, K082201. |
| Device Description: | The EasyGluco® Plus Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EasyGluco® Plus Test Strips. |
| The test principle is: | |
| This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result. | |
| Intended Use: | The EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of |
1
| | diabetes management in the home by patients with diabetes. The
EasyGluco® Plus Blood Glucose Monitoring System is intended to be
used by a single patient and should not be shared with any other person. |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | EasyGluco® Plus System is for self testing outside the body (in vitro
diagnostic use only) by people with diabetes at home as an aid to monitor
the effectiveness of diabetes control. The EasyGluco® Plus Blood
Glucose Monitoring System should not be used for the diagnosis or
screening of diabetes or for neonatal use. Alternative site testing should
be done only during steady-state times (when glucose is not changing
rapidly). |
| | The EasyGluco® Plus Blood Glucose Test Strips are for use with the
EasyGluco® Plus Blood Glucose Monitor for the quantitative
measurement of glucose (sugar) in fresh capillary whole blood samples
drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm,
calf or thigh. |
| Comparison to
Predicate Device: | The US Diagnostics, Inc. EasyGluco® Plus Module is substantially
equivalent to the other products in commercial distribution intended for
similar use. The most notable, it is substantially equivalent to the
currently marketed item, K082201-G5 Infinity Blood Glucose Monitoring
System. |
| Conclusion: | The EasyGluco® Plus Blood Glucose Monitoring System is substantially
equivalent to the following predicate devices:
K082201-G5 Infinity Blood Glucose Monitoring System |
:
2
Image /page/2/Picture/0 description: The image shows a logo with a circular border containing text, though the text is too blurry to read. Inside the circle is a stylized graphic of a bird in flight, depicted with three curved lines that suggest feathers or wings. The bird is facing left, and the overall design appears simple and symbolic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
US Diagnostics c/o Jonathan Johnson 304 Park Ave South Suite 218 New York. NY, 10010, US Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 21 2011
રિટ: K110435
Trade Name: EasyGluco Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class H Product Code: NBW, CGA Dated: August 22, 2011 Received: August 26, 2011
Dear Mr. Johnson:
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 fimited 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).
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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 Viro 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 of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.hum 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/Resources/orYou/Industry/default.htm.
Sincerely yours,
j
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K | | 0435
Device Name: EasyGluco® Plus Blood Glucose Monitoring System
Indication for Use:
The EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by patients with diabetes. The EasyGluco® Plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared with any other person.
EasyGluco® Plus System is for self testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The EasyGluco® Plus Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The EasyGluco® Plus Blood Glucose Test Strips are for use with the EasyGluco® Plus Blood Glucose Monitor for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forcarm, calf or thigh.
Prescription Use __ X (21 CFR Part 801 Subpart D)
And/Or .
Over the Counter Use X (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)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety