(233 days)
The EASYGLUCO™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. EASYGLUCO™ System is for testing outside the body (in vitro diagnostic use only). The EASYGLUCO Diabetes Monitoring System is not for use with neonatal blood specimens. Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, palm, calf and thigh.
The EASYGLUCO™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EASYGLUCO™ 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.
This 510(k) submission (K061431) for the EASYGLUCO™ G2 Blood Glucose Monitoring System provides a summary of the device and its intended use, but it does not contain the detailed study information or acceptance criteria you've requested.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It explicitly states in the "510(k) Summary" section: "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." This means it's designed to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to present a full clinical study report with detailed performance metrics and acceptance criteria.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This level of detail is typically found in the full submission, not the summary.
- Sample size used for the test set and the data provenance: Not mentioned in the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size: Not applicable for a blood glucose monitor, and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device, and not mentioned.
- The type of ground truth used: Not explicitly stated for performance evaluation, though for a blood glucose monitor, ground truth would typically be a laboratory reference method.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What the document does provide:
- Device Name: EASYGLUCO™ G2 Blood Glucose Monitoring System
- Predicate Device: LifeScan, Inc., OneTouch® Ultra® (K024194), LifeScan, Inc. SURESTEP® (K984261), Roche Diagnostics Corp. Accu-Chek Advantage (K021513)
- Device Description: An in vitro diagnostic device for measuring glucose in whole blood using a test strip with an electrochemical signal.
- Intended Use: Quantitative measurement of glucose in whole blood to monitor diabetes management in home and clinical settings, for in vitro diagnostic use only, not for neonatal blood specimens. Testing sites include fingertip and alternate sites (forearm, palm, calf, thigh).
To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to review the full 510(k) submission, which is much more extensive than the summary document provided here.
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IAN 1 2 2007
| 510(k) SUMMARY(As required by 21.CFR.807.92) | |
|---|---|
| Introduction: | According to the requirements of 21 CFR.807.92, the followinginformation provides sufficient data to understand the basis for adetermination of substantial equivalence. |
| Submitted By: | US Diagnostics, Inc.304 Park Avenue SouthSuite 218New York, NY 10010 |
| Contact Person: | Edward LetkoPhone: 917-402-5900Fax: 212-202-5173 |
| Date Summary,Prepared: | October 5, 2006 |
| Device Name: | Propriety Name: EASYGLUCO™ G2Common Name: Blood Glucose Test SystemClassification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,OneTouch® Ultra®. |
| DeviceDescription: | The EASYGLUCO™ Monitor is an in vitro diagnostic devicedesigned for measuring the concentration of glucose in wholeblood, which is used with the EASYGLUCO™ Test Strips.The test principle is:This device is an in vitro diagnostic product intended for themeasurement of glucose concentration in human blood. Theprinciple of the test relies upon a specific type of glucose in theblood sample, the dehydrogenase glucose that reacts to electrodesin the test strip. The test strip employs an electrochemical signalgenerating an electrical current that will stimulate a chemicalreaction. This reaction is measured by the Meter and displayed asyour blood glucose result. |
| Intended Use: | The EASYGLUCO™ Diabetes Monitoring System is used for thequantitative measurement of glucose level in whole blood as an aidin monitoring the effectiveness of diabetes management in thehome and in clinical settings. EASYGLUCO™ System is for |
| 510(k) Summary, Continued | |
| testing outside the body (in vitro diagnostic use only). TheEASYGLUCO Diabetes Monitoring System is not for use withneonatal blood specimens. Testing sites include the traditionalfingertip testing along with alternate site testing on the forearm,palm, calf and thigh. | |
| Comparison toPredicate Device: | The US Diagnostics, Inc.. EASYGLUCOTM G2 Module issubstantially equivalent to the other products in commercialdistribution intended for similar use. The most notable, it issubstantially equivalent to the currently marketed item, theOneTouch® Ultra® by LifeScan, Inc. |
| Conclusion: | The EASYGLUCOTM G2 Blood Glucose Monitoring System issubstantially equivalent to the following predicate devices:K024194 – LifeScan, Inc. OneTouch® Ultra®K984261 – LifeScan, Inc. SURESTEP®K021513 – Roche Diagnostics Corp. Accu-Chek Advantage |
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US Diagnostics, Inc. 510(k) for In Vitro Diagnostic Device
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward Letko Managing Director US Diagnostics, Inc. 304 Park Avenue South, Suite 218 New York, NY 10010-4301
Re: K061431
Trade/Device Name: EASYGLUCO G2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Blood Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 4, 2006 Received: December 5, 2006
JAN 1 2 2007
Dear Mr. Letko:
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 1 vire, 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 1egally 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 ontre 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 the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely 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:
Device Name: EASYGLUCOTM
Indications For Use: The EASYGLUCO™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. EASYGLUCO™ System is for testing outside the body (in vitro diagnostic use only). The EASYGLUCO Diabetes Monitoring System is not for use with neonatal blood specimens. Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, calf and thigh.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
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Carl Benson
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Office of In Vitro Diagnostic Device Evaluation and Safety
K06143/
Confidential American HealthCare, Inc.
§ 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.