3TEST SUPREME GLUCOSE MONITORING SYSTEM

K072905 · Neuero Engineering, Inc. · NBW · Apr 18, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072905
• Device Name: 3TEST SUPREME GLUCOSE MONITORING SYSTEM
• Applicant: Neuero Engineering, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 3test® Glucose Supreme Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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.

Device Story

System measures glucose in fresh capillary whole blood via amperometric assay using glucose oxidase enzyme. User applies blood to test strip; meter measures electrical current proportional to glucose concentration; converts current to glucose value. Device includes meter, test strips with 3 testing areas, lancing device, and control solutions. Used at home by patients or in clinical settings by professionals. Manual calibration code entry required per strip batch. Output displayed on meter screen; aids in monitoring diabetes control effectiveness. Benefits include portable, quantitative glucose monitoring.

Clinical Evidence

Pre-clinical and clinical data were employed per FDA Guidance for Industry for In Vitro Diagnostic Test Systems. No specific performance metrics (e.g., sensitivity, specificity) were provided in the summary document.

Technological Characteristics

Electrochemical biosensor; capillary action test strip; 2μL sample volume; 5-second measurement time; 200-result memory; battery-powered; standalone glucose meter.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the finger for individuals with diabetes (home/OTC use) or patients in clinical settings (professional use) to monitor diabetes control effectiveness.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 3test® Blood Glucose Monitoring System (K050224)

Submission Summary (Full Text)

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### 510(K) Summary of Safety and Effectiveness II.

(Per 21 CFR 807.92)

2.1. General Information Establishment

| 510(k): | K072905 |
|----------------------|----------------------------------------------------------------------------------------|
| Manufacturer: | NEUERO ENGINEERING INC. |
| Address: | 20F, No. 171, Cheng-Kuang Rd.,<br>San-Chung City, 24160, Taipei County, Taiwan |
| Registration Number: | 3004512547 |
| Contact Person: | Dr. Ke-Min Jen<br>Official Correspondent<br>886-3-5208829 (Tel)<br>886-3-5209783 (Fax) |
| Date Submitted: | October 1, 2007 |
| <b>Device</b> | |
| Proprietary Name: | 3test® Supreme Glucose Monitoring System |
| Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, OVER<br>THE COUNTER, Class II |
| Product Code: | NBW |

## 2.2. Safety and Effectiveness Information

#### ● Predicate Device:

Claim of Substantial Equivalence (SE) is made to NEUERO ENGINEERING INC.

-- 3test® Blood Glucose Monitoring System ( K050224 ).

- Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, 3test* Supreme Glucose Monitoring System only needs a small amount of blood ( 2μL. same as predicate device ). Capillary action at the

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end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 5 seconds, and 200 blood glucose result memory.

#### Intended Use: .

The 3test" Supreme Glucose Test Strip is intended to measure the glucose in whole blood with the 3test" Supreme Glucose Monitoring System. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The 3test" Supreme Glucose Monitoring System can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood.

#### . 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.

#### . Substantial Equivalence (SE)

A claim of substantial equivalence is made to the predicate device NEUERO ENGINEERING INC. -- 31est" Blood Glucose Monitoring System ( K050224 ). Both of them used with the same test strips, have the same working principle and technologies. The differences are the levels range of the control solution, battery number, the memory results, and test Strip lot calibration. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent,

Ke. Zizter

Dr. Jen, Ke-Min Official Correspondent for NEUERO ENGINEERING INC.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The overall design is simple and monochromatic.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Neuero Engineering, Inc. c/o Dr. Ke-Min Jen Official Correspondent 20F, No. 171, Cheng-Kuang Road San-Chung City, Taipei County 241 Taiwan, ROC

APR 1 8 2008

Re: k072905

> Trade Name: 3test Supreme Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA Dated: April 2, 2008 Received: April 7, 2008

Dear Dr. Jen:

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 [phone]. 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 [phone] or [phone] 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.

Yéan 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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# Indication for Use

510(k) Number (if known): k072905

Device Name: 3test Supreme Glucose Monitoring System

Indication For Use:

The 3test® Glucose Supreme Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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 _ 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)

Carol C. Benson

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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072905