3TEST GLUCOSE MONITORING SYSTEM

K050224 · Neuero Engineering, Inc. · NBW · Jul 13, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050224
• Device Name: 3TEST GLUCOSE MONITORING SYSTEM
• Applicant: Neuero Engineering, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

3test® Glucose Monitoring System uses electrochemical biosensor technology; capillary action draws whole blood sample into test strip chamber. Meter processes sample; displays glucose result in 5 seconds. Features 100-result memory. Used at home by patients or in clinical settings by healthcare professionals. Provides quantitative glucose levels to assist in diabetes management.

Clinical Evidence

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

Technological Characteristics

Electrochemical sensing using glucose oxidase and potassium ferricyanide. Hand-held meter with LCD display. Automatic calibration via lot-specific code chip. Powered by two 3V lithium batteries. Dimensions: 100x58x21 mm; Weight: 57g. Operating range: 57–104° F, 20-90% relative humidity. Sample volume: 2.0 µL. Test time: 10 seconds. Memory: 100 results.

Indications for Use

Indicated for use with the 3test Glucose Monitoring System to measure glucose in capillary whole blood from the fingertip. Suitable for home use by persons with diabetes and for professional use at clinical sites. Not for use with neonates.

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

• Glucometer Elite Blood Glucose Meter (K964630)

Submission Summary (Full Text)

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K050224

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

(Per 21 CFR 807.92)

JUL 1 3 2005

## 2.1. General Information Establishment

| Manufacturer: | NEUERO ENGINEERING INC. |
|----------------------|----------------------------------------------------------------------------------------|
| Address: | 20F, No. 171, Cheng-Kuang Rd.,<br>San-Chung City, 241, 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: | January 26, 2005 |
| Proprietary Name: | <i>3test®</i> Glucose Monitoring System<br><i>3TM678G</i> |
| Common Name: | Blood Glucose Monitoring System |
| Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, Class II. |

## 2.2. Safety and Effectiveness Information

- . Predicate Device:
Claim of Substantial Equivalence (SE) is made to BAYER Corp. -- Glucometer Elite Blood Glucose Meter ( K964630 ).

- Based on an electrochemical biosensor technology and the ● Device Description: principle of capillary action, 3test® Glucose Monitoring System only needs a small Capillary action at the end of the test strip draws the blood into amount of blood.
3

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the action chamber and your blood glucose result is precisely and displayed in 5 seconds, and 100 blood glucose result memory.

#### Intended Use: ●

The 3test® glucose test strip is intended to measure the glucose in whole blood with the 3test® Glucose Monitoring System. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The 3test® 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 BAYER Corp. --Glucometer Elite Blood Glucose Meter (K964630). Both of them have the same The differences are control solution, working principle and technologies. dimensions of the unit and strip, the time of auto shut off, memory results, and test There are no safety and effectiveness aspects arising from the subject time. device. They are substantially equivalent.

Ke-Mo-Ja

Dr. Jen, Ke-Min Official Correspondent for neuero engineering Inc.

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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 human figure with three flowing lines above it, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol in a circular fashion. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 1 3 2005

Neuero Engineering Inc. c/o Dr. Ke-Min Jen Cro Dr. its its interest Industrial Research Society No.58, Fu-Chiun St. Hsin-Chu City, China Taiwan 300

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k050224 Re:

K02022-1
Trade/Device Name: 3test Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: July 2, 2005 Received: July 6, 2005

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we have reviewed your Section 9 ro(t) premium in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreasure) to regally management date of the Medical Device American Frank Food. Drus commerce prof to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices mat have been recultion in accessariou of a premarket approval application (PMA). and Cosment ACT (Act) that do not require approvise the general controls provisions of the Act. The You may, merclore, market the device, bacycer of the more of registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 aco've) irrols. Existing major regulations affecting your cevice It may be subject to Such additional controllar Blassis on Parts 800 to 895. In addition, FDA can be found in Title 21, Cour of Concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does no mean Flease be advised that I Dri 3 issualise or our device complies with other requirements of the Act that I DA has made a decemination administered by other Federal agencies. You must of ally I edital statutes and regations and limited to: registration and listing (21 cumply with an the Free Frequire.nems 801 and 809); and good manufacturing practice CFR Part 8077, labeling (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 5 10(k) I his letter will allow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification: "The PDATmaing of bassana" - pur 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, of In If you desire specific information advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and and 1948 - Also moses of questions on the promotion and advertising or your and Safety at [phone]. Also, please note the Vitro Diagnostic Device Lyanaaton and Barey at (21)FR Part 807.97).
regulation entitled, "Misbranding by reference to premarket the Aat from the You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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 ): ূK 050224

Device Name: 3test® Glucose Monitoring System, 3TM678G-

Indications For Use:

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

NOTE:

- a. the 3test is to be used with capillary whole blood from the fingertip
- b. the 3test is not for use with neonates
- b. the stest meter is to be used with the 3test Blood Glucose Test Strip, and the 3test High and Low Glucose Control Solutions

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(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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In Vitro Diagnostic Device
Evaluation and safety

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