(156 days)
The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
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.
The provided text does not contain detailed information about acceptance criteria or specific study results for the EASYGLUCO™ device. The document is a 510(k) summary for an in vitro diagnostic device, primarily focusing on establishing substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set or data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The available information only describes the device, its intended use, and its substantial equivalence to other blood glucose monitoring systems. It does not include performance data or study design details.
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OCT 1 6 2003
American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device
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: | American HealthCare, Inc.304 Park Avenue SouthSuite 206New York, NY 10010 |
| Contact Person: | Edward LetkoPhone: 917-402-5900Fax: 212-202-5388 |
| Date Summary,Prepared: | April 18, 2003 |
| Device Name: | Propriety Name: EASYGLUCO™Common 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™ Monitoring System is used by individualswith diabetes. It is for the quantitative measurement of glucoselevels in whole blood, as an aid in monitoring the effectiveness ofdiabetes management in the home and in clinical settings. |
| Comparison toPredicate Device: | The Infopia Co., Ltd. EASYGLUCO™ Module is substantiallyequivalent to the other products in commercial distributionintended for similar use. The most notable, it is substantiallyequivalent to the currently marketed item, the OneTouch® Ultra®by LifeScan, Inc. |
| Conclusion: | The EASYGLUCO™ 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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American HealthCare, Inc.
510(k) for In Vitro Diagnostic Device
510(k) Summary, Continued
:
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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
OCT 1 6 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Edward Letko Managing Director American HealthCare, Inc. 304 Park Avenue South - Suite 206 New York, NY 10010
Re: K031501 Trade/Device Name: EASYGLUCO™ Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; CGA; JJX Dated: September 8, 2003 Received: September 9, 2003
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 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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 03 1501
Device Name: EASYGLUCO™
- Indications For Use: The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
Carol C Benam fo Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031501
X OTC use
§ 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.