GLUCODR SUPERSENSOR SYSTEM by ALL MEDICUS CO., LTD

The GlucoDr™ SuperSensor system is intended for in vitro diagnostic use (i. e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood from the fingertip.

The GlucoDr™ SuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home.

The GlucoDr"M SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus.

The GlucoDr™ SuperSensor system is not intended for use on neonates.

Device Description

The GlucoDr™ SuperSensor system consists of the GlucoDr™ SuperSensor Test Meter, GlucoDr™ SuperSensor Test strips and GlucoDr™ SuperSensor control solution. The GlucoDr™ SuperSensor system is based on measurement of electrical currents caused by the reaction of glucose with the regents on the glod electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents is proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ SuperSensor test meter.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The text provided is a 510(k) summary and related FDA correspondence for a medical device called the GlucoDr™ SuperSensor System, which primarily focuses on its substantial equivalence to a predicate device and its intended use. There are no details regarding specific performance metrics, test methodologies, sample sizes, or expert adjudication as requested in your prompt.

Summary

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OCT 7 - 2005

K050985

medical instruments / medical informatics

510(k) Summary

According to the requirements of 21 CFR.807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1. Submitter	All Medicus., Co. Ltd.
Name,	#7106, Dong-il Techno Town 7th.,
Address,	823, Gwanyang 2-dong, Dongan-gu, Anyang.
Contact
	Gyeonggi-do, 431-062, Korea
	Phone : (82) 31-425-8288
	Fax : (82) 31-422-8589
	Contact Person : Mr. Chang, Je Young
2. Date Prepared	Mar 07, 2005
3. Device Name	Propriety name : GlucoDr™ SuperSensor System
	Common name : Blood glucose monitoring system
	Classification name : Glucose Test System
	(21 CFR Section 862.1345, Product Code : LFR)
4. Predicate	We claim substantial equivalence to the Roche Diagnostics
Device	Corporation, Accu-Chek Advantage System. (K032552)
5. Device	The GlucoDr™ SuperSensor system consists of the GlucoDr™
Description	SuperSensor Test Meter, GlucoDr™ SuperSensor Test strips
	and GlucoDr™ SuperSensor control solution.
	The GlucoDr™ SuperSensor system is based on measurement ofelectrical currents caused by the reaction of glucose with the
	regents on the glod electrode strip. Glucose in the sample reacts
	with glucose dehydrogenase and mediators. This reaction creates
	electrical currents. The subsequent electrical currents is proportional
	to the glucose concentration in the blood and converted to the

	equivalent glucose concentration by the algorithm programmed in
	the GlucoDr™ SuperSensor test meter.

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The GlucoDr™ SuperSensor system is intended for in vitro diagnostic 6. Intended use use (i.e., for external use only) for quantitative measurement of glucose in capillary, venous, and arterial whole blood.
1. Comparison to The GlucoDr™ SuperSensor system has equivalent technological characteristics as the Accu-Chek Advantage System. The GlucoDr™ Predicate Device SuperSensor system also has the same intended use as the Accu-Chek Advantage System.
The GlucoDr™ SuperSensor system is substantially equivalent to the 8. Conclusion predicate device system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 7 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Je Young Chang All Medicus., Co.Ltd. 7106, Dong-il Techno Town 7th 823, Gwanyang 2-dong, Dongan-gu, Anyang Gyeonggi-do, 431-062, Korea

Re: K050985

Trade/Device Name: GlucoDr™SuperSensor Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW LFR, JJX Dated: September 30, 2005 Received: October 4, 2005

Dear Mr. Chang:

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely vours.

Carol C. Benson

Carol C. Benson, M.A. Acting 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 (if known):

Device Name: GlucoDr™ SuperSensor

Indications For Use:

The GlucoDr™ SuperSensor system is intended for in vitro diagnostic use (i. e., for external use only) for quantitative measurement of glucose in venous

whole blood and capillary whole blood from the fingertip.

The GlucoDr™ SuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home.

The GlucoDr"M SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus.

The GlucoDr™ SuperSensor system is not intended for use on neonates.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/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)

Rute Chalen

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510(k) K052985

Regulation Number and Section

§ 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.